Tensionable and lockable micro suture anchors and anchor arrays for anatomical attachment of soft tissue to bone

ABSTRACT

A toggle-type suture anchor that incorporates individual suture tensioning and locking without knot tying. The anchor includes an elongate toggle body having a working suture pre-threaded into a first passage and back up and out a second passage with a length running longitudinally adjacent the side of the anchor. A locking suture loop is pre-threaded into a third passage between the first and second passage and includes a collapsible loop that encircles a portion of the length of suture running longitudinally adjacent the side of the anchor. With the loop open, the working suture can slide through the anchor, however, when the loop is closed the working suture is locked in position to retain tension on the working suture. The anchor can be utilized in a pre-strung connected array of anchors.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 17/551,709, filed Dec. 15, 2021, titled TENSIONABLE ANDLOCKABLE MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICALATTACHMENT OF SOFT TISSUE TO BONE, which claims the benefit of andpriority to U.S. Prov. Pat. App. No. 63/172,565, filed Apr. 8, 2021,titled TENSIONABLE AND LOCKABLE MICRO SUTURE ANCHORS AND ANCHOR ARRAYSFOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. Prov. Pat.App. No. 63/281,411, filed Nov. 19, 2021, titled DELIVERY DEVICE FORIMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FORATTACHMENT OF SOFT TISSUE TO BONE, the disclosures of which areincorporated herein by reference.

BACKGROUND

Throughout the human body there are many attachments of soft tissue,such as tendons and ligaments, to bone as integral elements of motion infunctioning joints such as the shoulder. The shoulder joint includes thehumeral head of the upper arm bone in contact with the indentation ofthe glenoid working in conjunction with the rotator cuff, which is acombination of muscles and tendons forming a capsule that bothstabilizes the joint and causes desired motion. Injury to the connectionbetween tendons of the rotator cuff muscles to the humeral head, usuallya tear in a tendon, is common. These tears do not self-heal. It isestimated that in the U.S. over 4 million people annually are referredto a surgeon due to shoulder pain and over 500,000 of these referralsresult in shoulder surgery to repair the rotator cuff.

Significant effort has been expended over the past 30 years to developbone and tissue anchor devices and methods to respond to the need foreffective rotator cuff repair. Early methods and devices utilized anopen surgical technique that required a large incision of 4 to 6 cm andcutting the deltoid muscle, then re-attaching after the rotator cuffrepair. This method is still used today for massive tears by somesurgeons due to high success rate, however, the procedure is associatedwith deltoid dysfunction, significant pain during recovery and extensiverehabilitation time. Due to the invasiveness of the open surgery andresulting rehabilitation time, a “mini-open” procedure and associateddevices were developed in the early 1990's, wherein the surgeon usespartial arthroscopic techniques followed by an incision and split of thedeltoid muscle fibers to access the rotator cuff tendon for repair. Bythe late 1990's, devices and instruments were further developed tocomplete the repair of rotator cuff tendon attachment to bone usingall-arthroscopic techniques, with further resultant reduction in traumaand recovery time.

Arthroscopic repair of the rotator cuff tendon attachments to thehumeral head are the most common technique used today. However, it isrecognized that these all-arthroscopic techniques are quite difficult toperform and achieve varying results. The skill of the surgeon with thetechnology available is a known factor related to the procedure'ssuccess. Even with the last 20 years of all-arthroscopic technologicadvancement and experience, deficiencies persist as evidenced by studiesindicating an overall average rotator cuff repair failure rate of 20% to40%, with a highly variable range of 4% to 90% in individual studies.The study results indicate failure rates are much higher for large ormassive tendon tears and there are vast variations in failure ratesbetween surgeons, as well as with respect to various patient factors,equipment used, and type of repair completed.

There is significant controversy among professionals as to the reasonsfor the high incidence of arthroscopic rotator cuff repair failure (i.e.“re-tear of the rotator cuff”). However, studies clearly show there is aneed to reduce the failure rate of arthroscopic rotator cuff repair toavoid its effects of patients' lack of mobility, functional deficits,increased pain and/or requiring subsequent and more invasive surgerywith the attendant pain and rehabilitation. In particular, there isgreat concern for patients who have some degree of native tendon orrepair tendon failure yet choose to “live with it” rather than goingthrough a first or additional surgery and rehabilitation, thus affectingquality of life and promoting continued joint degradation from lack ofuse.

The basic device or devices used for repair of a tendon torn from a boneis one or more suture anchors in which a mechanical structure providesan anchor to the bone and a suture or sutures extend therefrom forattachment to the soft tissue or tendon. Many types of anchortechnologies have been proposed and used in procedures. A review of theprior art patent literature indicates over a thousand designs for sutureanchors, bone anchors, tendon repair systems, delivery devices andmethods espousing improved features over the past 25 years, yet repairfailure rate is still unacceptable indicating the need for furtherimprovement in the area of arthroscopic reattachment of tendons to boneand in particular in rotator cuff repair.

OVERVIEW

The present inventors have recognized, among other things, that aproblem to be solved is the need for new and/or alternative devices andmethods for arthroscopically affixing a tendon or other soft tissue tobone, such as in rotator cuff repair, with low failure rate, preferablyunder 10% on average, with little variation between surgeons, patientcharacteristics, and the system/method used for repair. The discloseddevices, systems, and methods, along with a statement of the problembeing solved by each element are included in summary form followed by adescription of specific claimed structure or methods in the presentdisclosure.

The present disclosure includes a total system for re-attaching a tendonthat has at least in part torn away from a bone attachment or footprint.The system is useful in repair of a rotator cuff tendon that has tornaway from a bone but can be used in other soft tissue and tendon repairprocedures. The system is particularly useful in repair of the rotatorcuff by reattaching a torn tendon, such as the most-commonly-tornsupraspinatus tendon, to the humeral head of the arm. In larger tears,the infraspinatus tendon may also be torn and amenable to repair withthis system. The repair is an anatomical repair, meaning that thesystem, devices and methods result in a repaired tendon and bonecombination that closely approximates the prior natural, anatomicrelationship between that tendon and bone to promote healing and providepain-free full function to the healed repair. An anatomical repair usingthe presently described system may also seal the tendon in position,taking advantage of local synovial fluid to aid healing and improvepost-surgery function. The system may also be used to reinforce partialtears and to secure areas beyond the region of a full-thickness tear asneeded. Further, the system, as implanted can dramatically reducerecovery and rehabilitation time due to the robust nature of the repairimmediately following surgery, requiring less time using a sling tolimit mobility and allowing early physical therapy to maintainpre-surgery mobility and strength during healing. It is believed time ina sling and complete recovery time can be reduced at least 50%, whilereducing the average failure rate to less than 10% with the currentdisclosed system.

As stated, in preferred examples, the exemplary rotator cuff repair isan anatomical repair in that the repaired tendon nearly duplicates orclosely approximates the natural tendon and bone relationship in thefully functional joint. For example, the tendon/tendons is/aresubstantially and completely re-attached to the original footprint onthe bone from which it was torn. The original footprint area providesthe greatest likelihood of healing re-attachment of the tendon to thebone while restoring anatomy. By substantially re-attached to theoriginal footprint it is meant that a substantial portion of theremaining torn tendon surface that was originally attached to thefootprint is re-attached thereto. The current system makes possibleclose approximation of the original tendon attachment by allowingtranstendinous or through the tendon implantation of each anchor. Thus,the tendon is held in the desired location when the anchor is installed,unlike current systems that insert anchors into exposed bone through atear and then use suture passers (which pass the suture when the tendonis not in position) to approximate where the surgeon believes the tendonwill pull down to the footprint. Further, the anatomical repair reducesmicromotion at the bone to tendon interface so that healing is promoted,even during movement of the joint. Finally, access to blood for healingis improved due to utilizing substantially more small holes in theproximal humerus that are not occluded by the implant sutures toaccommodate a large number of anchors in a close or high-density array.

In fresh cadaveric studies using the presently disclosed system, therepaired tendon and bone combination provides a tensile strength uponre-attachment of greater than 400 Newtons (N) and initial cyclic creepor gap formation of less than 2 millimeters (mm) when cycled to a peakload on the repaired tendon per cycle of 180 N. Initial cyclic creepmeasures the rigidity or robustness of the attachment of the tendon tothe bone as it measures how much the tendon slides or moves relative tothe bone attachment. Low initial cyclic creep allows the potential forfaster healing and less need for sling immobilization. Creep of lessthan 2 mm, or even less than 1 mm, is therefore a preferred outcome insome examples. In other words, if the tendon stays fixed in positionrelative to the bone it is compressed against (i.e. reducedmicromotion), the healing process will occur more quickly andpredictably than a situation that includes sliding of the tendon backand forth relative to the bone.

In selected embodiments, the anatomic repair requires a high-densityarray of knotless small anchors (requiring a bone hole size forinsertion of less than 3 mm) with close spacing between anchors (lessthan 7 mm edge to edge, or less than 10 mm hole center to hole center)to create anchor to subsequent anchor or serial anchor suture stitchesthat apply many points of constant independent force on the tendonagainst the bone. By independent it is meant that failure of one suturestitch to apply adequate force, as would happen if the suture stitchbroke, does not affect other suture stitches. Naturally, the number ofanchors utilized in a repair will depend upon the size of the tear.

It is recognized in the art that rotator cuff tears are classified intofour categories based on tear size and whether a single row or doublerow repair is completed. Small tears are less than 1 centimeter (cm) inlength; medium tears are 1 cm to 3 cm in length; large tears are 3 cm to5 cm in length and massive tears are greater than 5 cm in length. Withcurrent devices, surgeons are limited to available large anchors and bythe size of the tear as the medial anchors must fit in the tear areathat exposes bone. For example, surgeons may use about 1 medial anchoron small tears, 1 or 2 medial anchors on medium tears and 2 or 3 medialanchors on large tears and massive tears. With the high anchor densityanatomical repair of the present application, the surgeon is not limitedby tear size as the anchors are implanted through the tendon and can usegreater than 3 medial anchors on small tears, greater than 5 medialanchors on medium tears, and greater than 6 medial anchors on largetears and massive tears. This can include positioning implants outsidethe area of a full thickness tear to reinforce areas of partialthickness tears or weaker untorn tendon. Further, the present sutureanchors are designed for knotless tensioning and locking to expediteimplantation, maximize reproducibility amongst surgeons, and notinterfere with shoulder mobility from protruding knots while eliminatingthe tension variations that have been found in knotted suture anchorsdue to the difficulty of tying knots arthroscopically.

The suture anchors of the present disclosure are bar or toggle typeanchors wherein the basic structure for bone attachment is a thinelongate and/or cylindrical body having a cross sectional diameter ofless than about 3 mm and a length of about 6 mm to about 10 mm.Alternative sizes could be used in other applications in the body asdesired. Although described as generally cylindrical, it is recognizedthat certain surfaces can be machined or molded flat or grooved to allowfor suture strands to run alongside the implant when placed in acircular delivery tube. That is, rather than cylindrical, the presentanchors may be polygonal, for example, hexagonal or octagonal, or othercross-sectional shape. The anchor is a through the tendon ortranstendinous implant as described with respect to the delivery deviceand method below. Being transtendinous eliminates the requirement ofplacing the anchors only where the tendon is absent from the bone suchas in the hole formed by the tear or outside the tendon footprint.Furthermore, and importantly, the need for suture passing through thetendon is eliminated.

Transtendinous implantation with anchors used today entails technicalchallenges, including working a 3 mm to 6 mm diameter anchor through ahole created in the tendon with an awl, damaging the tendon. Further,threaded and flanged type anchor retention features of known, largeranchors, would damage the tendon during passing. With a toggle typeanchor, the anchor is inserted through a hole in the bone just largerthan the anchor axial outer diameter. Within the bone, the anchor istoggled (aka flipped or rotated) about 90 degrees, but at least 60degrees so that force applied to sutures extending from the toggle bodypull the length of the toggle body against the inner surface orunderside of the cortical shell of the humeral head. The degree to whichthe toggle body rotates or moves toward the cortical shell is affectedby the quality of the bone and by individual patient traits, such asage, sex, location of the hole in the bone and degree of bonedegradation due to the tear. The toggle body of the current invention isdesigned to toggle and seat with adequate pullout strength over therange of bone qualities encountered.

The toggle body functions in conjunction with a single suture line,referred to herein as the working suture which passes through at leastone passage formed through the toggle body. The number of passages canbe varied in the design of the toggle body as can the way in which theworking suture is threaded through the passages to provide desiredtensioning and locking functions. In some embodiments the toggle bodyincludes three holes passing through the toggle body generallyperpendicular to the longitudinal axis. In this embodiment the workingsuture passes through the top and out the bottom of a proximal hole,then back up through the bottom of a distal hole and out the top. Theworking suture is flossable or slidable as positioned through the twoholes by pulling with sufficient force on either working suture legextending out the top of the toggle body. On the bottom surface of thetoggle body, a length of working suture extends longitudinally past themiddle hole. A suture lock, which includes a separate piece of suture orthread or other flexible cord extends through the center hole, with anadjustable or collapsible loop or slidable knot which allows the loop tobe contracted, extending around the perimeter of a portion of theworking suture as it passes the middle hole. The other end of the suturelock cord extends from the top of the center hole. When the top end orproximal end of the suture lock is pulled, the adjustable loop collapsestight against the working suture and can pull at least a portion of theworking suture into the center hole to create a lock on the workingsuture so that it can no longer slide and will not slide under full loadas implanted.

In some embodiments, the tightening of the suture lock pulls a smallportion of the working suture into a slot or channel in the bottom ofthe middle hole in the anchor. The working suture is pinched in atortuous path that provides a sound lock and prevents sliding of theworking suture relative to the anchor once the suture is appropriatelytensioned. The strength of the lock is enhanced by the overall tortuouspath followed by the working suture when the anchor is pulled againstthe cortical shell as the working suture goes through several near90-degree turns which provide increased friction against the toggle bodyas well as the friction applied by the suture lock.

Each individual anchor includes features that assure it will implantproperly through the tendon in a hole punched through the cortical shellof the humeral head. The anchor is inserted lengthwise through this holeinto the spongy or cancellous bone. It is pushed by the point of a bonepunch that mates with a dimple formed in the proximal end of theimplant. The mating surface dimple is shaped to help maintain contactbetween the anchor and the punch while also allowing the anchor topivot, rotate, or toggle from an insertion configuration in which thecentral axis of the anchor is aligned with the central axis of the punchto an implant configuration in which the central axis of the anchor nolonger aligns with the central axis of the punch. The rotation ortoggling may have two parts: an initial change of axial direction as theanchor passes beyond the cortical shell into the cancellous bone duringadvancement as the punch is used to push the anchor, and a second changeof axial direction under tension applied using the working suture asdescribed below. The cancellous bone varies greatly in properties bylocation and patient ranging from very soft and porous to hard cellularstructures depending upon many patient-specific factors. The includedfeatures of the present anchor assure proper toggled retention withinthe bone over the range of cortical shell and cancellous bonevariations.

In selected embodiments, the implant preferably includes an acute angleon the distal surface with the upper side projecting furtherlongitudinally than the lower side. Inserted this way, the longerportion engages the cancellous bone and begins rotation during anchorinsertion. With both the distal and proximal portion of the workingsuture extending up through the bone hole, one can pull the distalworking suture selectively, which further rotates the implant body. Insome examples the rotation may be to an angle of about 90 degreesrelative to the central axis of the bone hole, though this extent ofrotation is not necessary to the inventive concept. It has been foundthat in hard cancellous bone, the pulling on the distal suture at timesmay not cause rotation because the proximal portion is held rigid by ahard layer of cancellous bone and therefore pulling causes the togglebody to back out of the hole and lie under the tendon. To prevent this,the implant includes a fin or fins on the proximal portion that upondelivery project proximally and radially with a cross dimension greaterthan that of the bone hole. The size of the fins prevents back out ofthe anchor but also the fins are located to project and to catch on thecancellous bone and assist in rotation. The fins alone may notaccommodate the full pullout force in some examples, rather the toggleanchor must rotate as well so that the force pulling on the anchor iscarried by the side wall of the toggle body as rotated.

The single working suture is pre-strung through a plurality of anchorsto be used as a set to form an implanted array having a tensioned suturestitch extending from one anchor to the subsequent anchor in thepre-strung chain. As previously stated, each anchor is slidable orflossable with sufficient force applied to move along the workingsuture. Each anchor is equipped with a suture lock as described above,except the first anchor in the chain which can have a standard suturelock or a fixed non-slidable suture connection. A chain of anchors cancarry in the range of about 8 to 12 anchors in some preferredembodiments.

The high-density array of anchors is formed by implantation of theanchors in a chain or row which can be a relatively straight line orcurve depending upon the tear to be repaired at the discretion of thesurgeon. A delivery device system designed for sequential transtendinousimplantation of each anchor in the array is disclosed herein as well.The delivery system includes a delivery tool distal portion to be usedat the surgical site for implantation of the array, and a proximalportion having a handle and features for managing the anchors andassociated sutures and suture lock. The distal portion of the deliverytool includes an anchor delivery tube sized to allow passage of ananchor and associated working suture and suture lock therethrough. Thedelivery tool is used with a bone punch that is sized as well forpassage through the anchor delivery tube. The proximal portion of thedelivery tool is configured to allow a physician to introduce an anchorthat is pre-strung onto the working suture into the anchor deliverytube. The proximal portion of the delivery tool may include a platformfor receiving a magazine carrying a number of cartridges that house thepre-strung anchors individually. The magazine may include a cartridgeejector that allows one cartridge at a time to be removed from themagazine and placed in a slot on the delivery tool. A plunger is used totransfer individual anchors from the cartridge to a lumen at theproximal end of the anchor delivery tube.

In use, the physician places the distal end of the delivery tool at adesired location for introduction of an anchor. Such placement may beperformed with the bone punch extending past the distal end of thedelivery tool to allow a physician to probe the desired location usingthe bone punch. The physician then presses the delivery tool distal endagainst the tendon and applies a force, such as by pounding, against theproximal end of the bone punch to create a path through the tendon andthen to create a bone hole. The distal end of the anchor delivery tube,referred to as a nub, may be advanced through the tendon and at leastpartly into the bone hole as the bone punch is pounded.

The bone punch is then retracted, while the nub is kept in place tomaintain registration through the tendon and into the bone hole. Withthe bone punch retracted, a cartridge is removed from the magazine usingthe cartridge ejector and transferred to the slot on the proximalportion of the delivery tool, and the plunger is depressed to move ananchor from the cartridge into position for advancement into the anchordelivery lumen. The bone punch is again advanced, this time pressingagainst the proximal end of the anchor, eventually ejecting the anchorfrom the anchor delivery tube into the bone hole. As the bone punchpushes the anchor down the anchor delivery tube, the tip of the bonepunch is engaged with the dimple. The anchor delivery tube may be sized,relative to the anchor, to compress the fins as the anchor passesthrough the anchor delivery tube to a reduced outer dimension.

When the anchor exits the anchor delivery tube, the fins expand to theirfull relaxed diameter, reducing the potential for the anchor to back outof the bone hole. In some examples, the relaxed diameter of the fins islarger than the size of the bone hole. The bone punch is advanced sothat the tip of the bone punch extends beyond the nub, forcing theanchor into the bone. As the anchor advances into bone, the angleddistal surface enters the bone first, and begins to turn or toggle theanchor. The dimple is configured to allow the anchor to turn withouttorqueing against the distal tip of the bone punch, allowing the anchorto toggle as it is advanced. The bone punch is then retracted into theanchor delivery tube, and the working suture is manipulated to continuetoggling the anchor into a position which is preferably parallel to thebone surface, though less than complete toggling may still provide ausable anchor position particularly in harder bone. To preventinterference between the anchor and the anchor delivery tube and/ordamage to the working suture during toggling of the anchor, the anchordelivery tube may be retracted so that the nub is within the deliverytool. In addition, retracting the anchor delivery tube and/or nub canreduce flossing tension, allowing flossing of the working suture untiltensioned; once tensioned relative to a prior anchor, toggling isfurther aided.

On this first anchor only, the working suture may be locked intoposition using the locking suture prior to using the working suture totoggle the anchor, or even prior to starting implant of the firstanchor, if desired, as no anchor to anchor stitch can be formed until asecond anchor is implanted. In some examples, the first anchor may beaffixed to the working suture, and the locking suture may be omitted forthe first anchor. When the first anchor is set in sufficiently strongmaterial inside the bone (which can be harder cancellous bone or may beresting against the under surface of the cortical shell) the deliverydevice can be set with the punch pin partially extended as it was at thebeginning of the procedure and moved for implantation of the nextanchor.

With the second and subsequent anchors, both a proximal and a distalsuture portions of the working suture extend up through the deliverydevice. It is the distal portion of the working suture that is pulled tocause rotation of the anchor while also allowing the working suture toslide through both holes in that anchor and the slack extending to thedistal hole of the previous anchor is therefore shortened. It is alsorecognized that the proximal portion of the working suture can betensioned in some embodiments to aid in rotating and seating the anchorin proper position within the bone hole. During toggling of the anchorand subsequent tensioning of the suture, the distal end of an outer tubeof the delivery tool may be pressed against the tendon to provide acounterforce against pullout. This is continued until the properlytensioned suture stitch is formed at which point the suture lock on thesecond or subsequent anchor is activated to maintain tension in theindividual suture stitch. The locking suture proximal extension can becut off after tightening or a selectively breakable suture can be usedand such breakable portion is positioned proximate to and proximal ofthe slidable knot.

This is repeated for a desired number of anchors in the pre-strung chainwhich is implanted to form a high-density array as described above. Ascan be understood, the number of suture stitches formed is equal to thenumber of anchors in the chain implanted minus 1. Further, the string ofstitches is serially continuous with each stitch tensioned and lockedindependently to form a required robust tendon attachment. Thecontinuous string of stitches can form a row or chain of stitches ofdesired shape such as a linear row, a zig-zag shape, an arc, etc. By rowor chain, it is meant that the suture stitches extend from one anchor tothe next in the sequence of implanted anchors. It is understood thatmore than one continuous string of stitches can be formed by implantingmultiple anchor arrays that together form an overall repair array,especially for large tears.

As previously stated, the distance between ends of a suture stitch (thedistance between anchors) is preferably less than about 7 mm (less thanabout 10 mm from center of hole to center of hole) to provide consistentforce on the tendon against the bone to reduce creep. One particularlyrobust array of implanted anchors includes a first array implanted in amedial portion of the original tendon footprint to form a row or line ofstitches generally perpendicular to the length or direction of thetendon's forces. A second array can then be implanted laterally nearerthe edge of the tear with at least one anchor through the tendon whileat least one other anchor is implanted laterally of the tendon edge toreapproximate the tendon properly against the bone. The lateral row canbe implanted in a zig zag pattern or other appropriate pattern based onthe shape of the tear. Depending upon tear size and location, multiplepatterns can be utilized.

As becomes clear in the above description, the pre-strung array ofanchors in combination with the working suture and multiple lockingsutures creates a strong need for a delivery system that has componentsthat manage the anchors and their attendant sutures or suture sectionsto maintain orderly implantation, use and sterility during a procedure.Further, the small size of the anchors necessitates some sort of holderor cartridge for individual anchors. Applicants disclose herein anattachable magazine and multi-cartridge assembly that integrates withthe above-described delivery device. The assembly includes a cartridgefor each anchor in a given array with the individual cartridges storedand managed in a cartridge magazine in a way that maintains theintegrity of the array and allows the surgeon to access and use eachanchor in the array sequentially.

The overall design of the anchor may include the following features. Theanchor may include a distal end having an angled leading surface toencourage the anchor to begin to toggle as it exits the anchor deliverytube and nub. The anchor has a bottom side and a top side, with thebottom side being shorter than the top side due to the angled leadingsurface. The anchor may include a proximal end having a pair of fins oneither side of a depression or dimple to receive the distal tip of thebone punch during insertion, where the dimple loosely receives thedistal tip of the bone punch to allow the anchor to begin to toggle asit exits the anchor delivery tube and nub. The fins are adapted to becompressed while in the anchor delivery tube and to then open up afterexiting the anchor delivery tube to discourage backing out of the anchoras it is toggled into its final position. The anchor also includesproximal and distal holes for passing the working suture therethrough,and a middle hole that allows a locking loop or cord to passtherethrough. The middle hole may include a platform that provides asurface against which the locking loop can be compressed when the freeend of the locking loop is tensioned, allowing the locking loop totighten onto and affix the working suture.

A pre-strung anchor may then be configured with the working suturepassing into the proximal hole from the top of the anchor, out of thebottom side and then along the bottom side of the anchor to the distalhole. The working suture may extend up through the distal hole and exitsat the top side. A locking loop extends out of the middle hole andsurrounds the working suture. A pre-strung array of anchors may includea plurality of anchors disposed along a single working suture, with eachanchor having its own locking loop. Alternatively, a pre-string array ofanchors may include a first anchor that is permanently affixed to thesingle working suture, and a plurality of additional anchors eachdisposed along the single working suture and each having its own lockingloop. Each locking loop may include a free end that can be tensioned tolock the working suture of an anchor to the anchor once implanted andtensioned.

Following are a number of illustrative and non-limiting examples. Thespecific features identified in these examples may be studies inconjunction with the overall system and may be further understood byreference to the following detailed description and attached Figures.

A first illustrative and non-limiting example takes the form of atoggle-type suture anchor comprising: an elongated toggle body having atleast a first and a second hole through the toggle body extending from afirst longitudinal surface to a second longitudinal surface of thetoggle body, each hole located at a spaced interval along the togglebody; a suture passing into the first hole at the first longitudinalsurface and out the first hole at the second longitudinal surface, thenback up through the second hole at the second longitudinal surface andout the second hole at the first longitudinal surface, with a length ofthe suture extending adjacent the second longitudinal surface betweenthe first and second holes, wherein the suture is adapted to slidethrough the first and second holes when a force is applied thereto; anda locking loop which encircles the suture along the second longitudinalsurface between the first and second holes, the locking loop beingadjustable between a first position allowing the suture to slide throughthe locking loop and a second position engaging the suture andpreventing sliding within the locking loop.

Additionally or alternatively, the toggle-type suture anchor may furthercomprise a third hole through the toggle body extending from the firstlongitudinal surface to the second longitudinal surface and locatedbetween the first and second holes, wherein the locking loop extendsfrom the third hole at the second longitudinal surface after passingthrough the toggle body. Additionally or alternatively, the locking loopincludes a cord having a free end extending through the third hole andbeyond the first longitudinal surface, the cord having at least aslidable knot tied therein to allow collapsing of the locking loop fromthe first position to the second position when the free end istensioned.

Additionally or alternatively, the third hole has an upper portion forreceiving the slidable knot at least partially therein from the firstlongitudinal surface wherein the upper portion terminates in a platformwithin the third hole that does not allow passage of the slidable knotout to the second longitudinal surface. Additionally or alternatively,the locking loop has first and second legs, and the third hole includesa lower portion having an oval shape for allowing both legs of thelocking loop to pass therethrough side by side and out the secondlongitudinal surface.

Additionally or alternatively, the slidable knot is at least a 4-throwuni knot.

Another illustrative and non-limiting example takes the form of atoggle-type suture anchor comprising: an elongate body having a proximalpassage, a middle passage, and a distal passage extending from a topsurface to a bottom surface, each passage located at spaced intervalsalong the elongate body with the middle passage between the proximal anddistal passages; a single suture passing into the proximal passage atthe top surface and out at the bottom surface, then back up through thedistal passage at the bottom surface out the top surface leaving alength of suture extending past the middle passage adjacent the bottomsurface; and, a locking loop extending from the middle passage at thebottom surface which encircles a portion of the length of the sutureextending adjacent the middle passage along the bottom surface, thelocking loop having a first open position allowing the suture to slidethrough the locking loop and a second closed position engaging thesuture and preventing sliding of the suture within the locking loop.

Additionally or alternatively, the elongate body further comprises: apair of fins extending both proximally and laterally outward from theelongate body proximal to the proximal passage, wherein at least aportion of each fin extends further laterally beyond a maximum lateraldimension of the elongate body. Additionally or alternatively, thelocking loop extends from the middle passage bottom surface and includesa tightening leg extending through the middle passage and out the top ofthe middle passage. Additionally or alternatively, the locking loopcomprises a cord having at least a slidable knot tied therein on thetightening leg to allow manipulation of the locking loop from the firstopen position to the second closed position when the tightening legthrough the middle passage is tensioned. Additionally or alternatively,the middle passage has an upper portion for receiving the slidable knotat least partially therein from the top surface that terminates in aplatform within the toggle body that does not allow passage of theslidable knot to the bottom surface. Additionally or alternatively, thelocking loop has first and second legs, and the middle passage includesa lower portion having an oval shape for allowing both legs of thelocking loop to pass therethrough side by side and out the bottomsurface. Additionally or alternatively, the slidable knot is at least a4-throw uni knot.

Another illustrative and non-limiting example takes the form of atoggle-type suture anchor comprising: an elongate body having agenerally flat top and bottom surfaces and rounded side surfaces, therounded side surfaces defining a maximum diameter of the elongate bodyand each of a proximal, a middle and a distal passage extending from thetop surface to the bottom surface, each passage located at spacedintervals along the elongate body with the middle passage between theproximal and distal passages; a single suture passing into the proximalpassage at the top surface and out at the bottom surface, then back upthrough the distal passage at the bottom surface out at the top surfaceleaving a length of suture extending past the middle passage along thebottom surface; and a locking suture having a collapsible loop formedtherein and a tightening leg extending from the collapsible loop, withthe collapsible loop extending from the middle passage at the bottomsurface to encircle a portion of the length of the suture extending pastthe middle passage along the bottom surface, the tightening legextending through the middle passage to the top surface, the collapsibleloop configured to close in response to tension on the tightening leg inthe direction of the top surface.

Additionally or alternatively, the locking suture is a flexible cordhaving sufficient length to extend through the middle passage and beyondthe top surface during use. Additionally or alternatively, the lockingsuture comprises a cord having at least a slidable knot tied therein toallow collapsing of the loop when the tightening leg through the middlepassage is tensioned. Additionally or alternatively, the middle passagehas an upper portion for receiving the slidable knot at least partiallytherein from the top surface that terminates in a platform within themiddle passage that does not allow passage of the slidable knot.

Additionally or alternatively, the collapsible loop has first and secondlegs, and the middle passage includes a lower portion having an ovalshape for allowing both legs of the locking loop to pass therethroughside by side and out the bottom surface. Additionally or alternatively,the slidable knot is at least a 4-throw uni knot. Additionally oralternatively, the middle passage oval portion is sized to allowmovement of at least a portion of the single suture to be pulled thereinin response to tension on the locking suture.

Another illustrative and non-limiting example takes the form of acombination toggle-type suture anchor and pre-threaded suture comprisinga toggle body having first, second and third holes passing therethroughin a parallel relationship to one another, a first suture passingthrough the first hole in a first direction and then through the thirdhole in a second direction opposite the first direction, and a secondsuture having a free end and a locking loop, the locking loop encirclingthe first suture and the free end passing through the second hole, thesecond suture configured to close upon the first suture when a force isapplied to the free end.

Additionally or alternatively, the locking loop includes a slideableknot. Additionally or alternatively, the second hole has an upperportion for receiving the slidable knot at least partially therein and aplatform within that does not allow passage of the slidable knottherethrough. Additionally or alternatively, the locking loop has firstand second legs, and the second hole includes a lower portion having anoval shape for allowing both legs of the locking loop to passtherethrough side by side. Additionally or alternatively, the slidableknot is at least a 4-throw uni knot. Additionally or alternatively, themiddle passage oval portion is sized to allow at least a portion of thesingle suture to be pulled therein in response to tension on the lockingsuture.

This overview is intended to introduce the subject matter of the presentpatent application. It is not intended to provide an exclusive orexhaustive explanation. The detailed description is included to providefurther information about the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIGS. 1A-1E are various views of a representative toggle body;

FIGS. 1F-1G are views of alternative fin orientations in a toggle body;

FIG. 1H is partial cut-away view of a toggle body with a working sutureand locking suture in an open position illustrated;

FIG. 1I is partial cut-away view of the toggle body of FIG. 1H having aworking suture and locking suture in a closed position illustrated;

FIG. 1J is a schematic illustration of the interaction between thelocking suture and the working suture;

FIG. 1K is a schematic illustration of an alternative interactionbetween the locking suture and the working suture;

FIG. 2A is an illustration of a pre-threaded array of toggle typeanchors;

FIG. 2B is an alternative view of FIG. 3A showing the toggle anchors incross section to illustrate the threading route of the sutures;

FIGS. 3A-3C are perspective views of an example anchor delivery devicein several configurations;

FIGS. 3D-3F are close up views of the distal end of the anchor deliverydevice corresponding to FIGS. 3A-3C;

FIGS. 3G-3I are partial cut-away views of the anchor delivery device inseveral configurations;

FIGS. 3J-3N are partial cut-away views illustrating the interaction ofinternal components of the anchor delivery device;

FIG. 3O is a partial cut-away view of the anchor delivery device inanother configuration;

FIGS. 3P and 3Q display features of an illustrative anchor deliverytube;

FIG. 3R illustrates coupling of the punch head;

FIGS. 4A-4D illustrate features of a plunger for securing cartridges tothe anchor delivery device;

FIGS. 5A-5D illustrate a cartridge for holding a toggle anchor;

FIG. 5E illustrates interaction of a cartridge of FIGS. 5A-5D with aplunger as in FIGS. 4A-4D; and

FIGS. 6A-6I illustrate the steps for implanting exemplary anchors of thecurrent invention and resulting pattern of continuous tensioned andlocked anchor to anchor single suture stitches.

DETAILED DESCRIPTION

The present invention includes multiple components, devices and methodsto create and use an overall system for reattaching soft tissue to bone.It is particularly useful to create a robust repair of torn tendons,such as the supraspinatus tendon, in an arthroscopic rotator cuffrepair. The implants and delivery devices make possible a faster, easierand lower failure rate anatomical repair. The tendon is securelyattached and held with adequate force to its original footprint withvery little creep during movement of the joint. This decreases apatient's time in a sling, increases the rate of healing reattachment oftendon to bone and allows early physical therapy to maintain range ofmotion and strength.

The implanted array of anchors with a continuous set of anchor-to-anchorsingle suture stitches creates a seam-like attachment akin to a sewingmachine construct. Further, the small cross-sectional size of theanchors (less than 3 mm in diameter) allows the anchors to be placed inclose proximity to one another (less than about 7 mm between adjacentanchors). This creates an anchor to anchor suture stitch. Combining thisconcept with the disclosed anchor design allows the suture stitch to betightened and locked individually when the adjacent suture anchors areimplanted. This can be repeated many times to implant a row of anchorswith continuous independently tensioned and locked stitches betweenadjacent anchors. Also, because the anchors are in a high-density array,the tension force components on the tensioned suture are more verticallyapplied to the top surface of the tendon (or other connective tissue) tothereby hold the tendon against the footprint of the bone without creepor slippage during joint movement.

FIGS. 1A-1K are a series of illustrations of exemplary toggle bodies ortoggle-type anchors that can be used in a procedure for attaching tendonto bone. The illustrations also show a single working suture slidablydisposed in passages through the anchor and through a locking loop. Thelocking loop is configured to have an open position allowing movement ofthe single working suture, and a closed or locked position that preventsmovement of the single working suture.

Referring to FIG. 1A, a perspective view of a representative anchor inthe form of a toggle body 100 is illustrated. The toggle body 100 can bean elongate body 101 having a length defined by a proximal end 102 and adistal end 104. The elongate body 101 can be a generally cylindricalbody but other shapes are possible. For example, as shown in FIG. 1A,the toggle body 100 is generally cylindrical but the top surface 105 andbottom surface 107 have flat axially-extending surfaces that allow roomfor sutures when the toggle body 100 is in a round delivery tube. Thelength of the toggle body 100 is substantially longer than the diameterthereof, allowing the toggle body 100 to be inserted lengthwise oraxially into a small bone hole. Once inserted, unlike most anchors usedtoday, the entire body is pivoted or toggled so that it stays within thebone and has substantially its entire length compressed against materialinside the bone. That is, the longitudinal axis of the toggle body 100is rotated or pivoted from the direction used to insert through the bonehole, thereby preventing removal. This approach means that removal wouldrequire the anchor itself to fail, rather than simply being releasedfrom surrounding tissue, and provides high pullout strength (greaterthan 600 N before anchor failure when implanted in the array disclosedherein) from an anchor requiring a very small insertion hole (less thanabout 3 mm). As previously stated and described in detail below, smallinsertion holes allow much closer placement of anchors in a high-densityarray.

The toggle body 100, can have a length of about 6 mm to about 10 mm insome embodiments. This length gives adequate strength while leavingenough room inside the bone for the high number of anchors implanted.The toggle bodies are preferably molded or machined from a polymericmaterial, preferably a high tensile strength material such apoly-ether-ether ketone (PEEK) which is highly biocompatible. Inapplications where MRI imaging would not be an issue, metal can beutilized in part or all of the toggle body.

Referring now also to FIGS. 1B (top view) and 1C (bottom view), it canbe seen that the toggle body 100 can include a number of holes orpassages through the cross section of the toggle body 100. Asillustrated, the toggle body 100 has a proximal bore or passage 110, amiddle passage 108 and a distal passage 106. The passages 106, 108, 110extend from the top surface 105 to the bottom surface 107 such that thepassages 106, 108, 110 extend through the cross section of the elongatebody 101. In other embodiments, the toggle body may have fewer or morebores or passages, such as having a single bore, two bores, or more thanthree bores. In the illustrated embodiment, the proximal passage 110 anddistal passage 106 receive a portion of a common working suture slidablewith respect to the toggle body 100 during use. The middle passage 108receives a locking suture which is independent for each anchor used inan array of anchors.

The distal end 104 of the toggle body 100 has an angled surface. Asshown, the angled surface creates a longer upper longitudinal surface105 than lower longitudinal surface 107. In other words, the uppersurface projects a greater distance distally than the lower surface.This is useful during insertion of the toggle body 100 because theprojecting distal surface plows into cancellous spongy bone whenimplanted to initiate at least partial rotation of the toggle bodyduring insertion. Keeping in mind that the present toggle bodies 100 arepreferably implanted through the tendon, it is important that the togglebody 100 toggle every time or it may pull out of the bone hole undertension yet not be visible as it will be under the tendon.

The proximal end 102 of the toggle body 100 can include one or moreprojecting fins 112. The illustrated embodiment includes two fins 112.Each fin 112 projects outward and proximally. Further, in someembodiments, as depicted, the fins 112 project downward as they extendproximally. The function of the fins 112 is best understood withreference to FIGS. 1D and lE which are distal and proximal end views ofthe toggle body 100, respectively. A reference circle 113 is includedwhich indicates the general maximum cross section or diameter of theelongate body 101. The bone hole in which the implant will be placed issized to closely match this dimension, as is the inner diameter of adelivery tube used to deliver the implant. In contrast, as shown, thefins 112 each project laterally beyond the outer cross section ordiameter of the elongate body. During insertion the fins 112 flex inwardunder compressive force due to contact with the inner diameter of adelivery tube to fit in the bone hole.

Once delivered and released from compressive forces of the deliverytube, the fins 112 relax to a size greater than the bone hole. In somepreferred embodiments, each fin tip extends about an additional 0.5 mmbeyond the size of the bone hole where that feature is inserted. Suchfin tips may also be described as extending about 0.5 mm beyond themaximum outer diameter of the rest of the anchor body, for example, inthe range of 0.4 mm to 0.7 mm. This feature provides an added safeguardagainst the toggle body 100 backing out of the bone hole under tensionif the toggle body 100 has not adequately toggled. Further, the fins 112are positioned so that tension on the toggle body 100 causes thepartially toggled anchor to grab cancellous bone and further rotate theanchor.

Alternative designs of the fins 112 are also depicted in FIGS. 1F and1G. The fins 112 in these figures have alternative positions on theelongate body 101 and direction of proximal extension. The fins 112 ofFIG. 1F are widest at a centrally located position to keep the anchorcentered in the delivery tube since the largest dimension is horizontalat the diameter of the tube during delivery. In some examples, the finsdo not provide the pullout strength necessary for the implanted anchorto reattach the tendon. As previously stated, in preferred examples,each anchor toggles so that the full length of the anchor is pressedagainst interior bone structure to provide adequate pull out strength.

The top and bottom views of FIGS. 1B and 1C show details of the proximal110, middle 108 and distal 106 passages. In particular, the middle holehas a platform 114 formed within the elongate body 101, part way throughthe cross section. That is, in this example, the middle passage 108 hasa change in size or shape partway along its length, to define a platform114. From the bottom view, it can be seen that the middle passage 108continues from the platform 114 with a slotted or oval shape or portion111, while having a circular profile from the top view. The function ofthese passages is detailed in the cross-section perspective views ofFIGS. 1H and 1I wherein representative cords or sutures 115, 116 havebeen pre-strung on the toggle body 100.

First, there is a single suture, called herein the working suture 115that extends into the proximal passage 110 from the top surface, andextends out at the bottom surface. The working suture 115 then extendsup through the distal passage 106 from the bottom surface and outthrough the top surface. This leaves a section 117 of the working suture115 extending past or adjacent the middle passage 108 along the bottomsurface. The working suture 115 can be flossed or is slidable throughthe distal 106 and proximal passage 110, meaning the toggle body 100 canslide on the working suture 115 when tension is applied. Second there isa locking loop 118 that encircles a portion of the section 117 of theworking suture 115 extending adjacent the outer surface of the togglebody 100 between the proximal 110 and distal 106 passages. The lockingloop 118 has a first open position as depicted in FIG. 1H wherein theworking suture 115 is free to slide through the locking loop 118 and asecond closed position depicted in FIG. 1I wherein the locking loop 118engages the section 117 and prevents it from sliding within the lockingloop 118. Several examples refer to a suture, cord, or thread, which canbe used as the working suture 115 or in the locking loop 118. Theseelements may be, for example, made of natural material such as silkand/or synthetic materials such as polyglycolic acid, polylactic acid,and polydioxanone, each of which are known for use as absorbablesutures, and/or nylon and polypropylene, which are typicallynon-absorbable. Various coatings, including antimicrobial, anti-wickingor lubricious coatings may be applied as well. More broadly, theseelements 115, 118 may include any item that can be used to coupletogether objects in a surgical environment, such as any sufficientlybiocompatible metal, natural material, plastic or other artificialmaterial adapted for use in a surgical procedure. Monofilaments or morecomplex structures including braids, weaves, windings, twisted threads,coated or multilayer member, etc. may be used.

In the embodiment depicted, the locking loop 118 extends from the bottomsurface of the toggle body 100 through the middle passage 108. Thelocking loop 118 includes a cord or suture having at least a slidableknot 120 tied therein to allow collapsing of the locking loop 118 when afree end or proximal end 121 of the suture lock 116 extending throughthe middle passage 108 is tensioned. As shown, the upper portion of themiddle passage 108 is sized to receive at least a portion of theslidable knot 120 therein. The slidable knot 120 then contacts thesurface of the platform 114 which does not allow the knot to passthrough towards the bottom opening. The lower oval portion 113 of themiddle passage 108 is a slot or oval which allows both legs of thelocking loop 118 to pass therethrough, preferable side by side in theslot direction. The interaction of these components locks the workingsuture 115 with respect to the toggle body 100.

As shown, especially seen in FIG. 1C and 1I, the bottom of the togglebody 100 includes a channel 125 formed in the bottom surface 107 betweenthe proximal 110 and distal 106 passage. When the working suture 115 istensioned, it is pulled up into this channel 125 which is sized to makethe suture less able to floss or move therethrough by increasingfrictional resistance to such movement, but does not lock the suture.Further, the working suture then has two near 90-degree angle turns atthe bottom openings of the distal 106 and proximal 110 passage whichalso make it more difficult to floss, but do not lock the working suture115. The locking loop 118 closing around the working suture 115 andpulling it toward and at least partially into the slot or oval portion113 is the structure that locks the suture so that cumulative frictionprevents slippage of the working suture 115.

In the illustrative example shown in FIGS. 1H to 1K, the free end 121 ofthe suture lock 116 is configured to break away from the locking loop118 proximal of the sliding knot 120. A break knot is illustrated at 122and is one example of a way of introducing weakness in the suture lock.The break knot 122 is located a distance above the sliding knot 120,sufficient that when the suture lock 116 breaks away, the sliding knot120 remains intact and secure; for example, 3 to 10 mm proximal of thesliding knot, or more or less. Rather than a break knot 122, a nick orother point of weakness may be imparted at the desired or preferentialpoint of failure in the suture lock 116.

FIGS. 1J and 1K depict the way in which the locking loop 118 pulls thesection 117 of the working suture 115 into the oval portion 113 in twodifferent embodiments. The degree to which the section 117 of theworking suture 115 enters the slot 113 will be dependent upon how tightthe loop is closed, the size of the locking suture and the size of theslotted opening. In preferred embodiments, at least a portion of thecross section of the working suture 115 is pulled into the slot so thatthe edge surfaces of the slot walls provide significant friction and aidin locking. In another example, the preferential point of failure isdesigned to allow the locking loop 118 to be drawn into the slot beforethe failure occurs.

The locking loop 118 in combination with the design of the middlepassage 108 is an assembly for locking a slidable working suture 115when tensioned in a suture toggle body 100 during tissue fixation tobone. The locking loop 118 encircles a portion of the working suture115, wherein collapsing the locking loop 118 compresses the crosssection of the working suture 115 to lock the working suture 115 whentensioned. The suture lock 116 is preferably formed of a suture havingat least a slidable knot 120 tied therein to form the loop 118 to allowcollapsing of the loop 118 when a tightening leg 121 through the secondpassage 108 is tensioned. The second passage 108 has an upper portionfor receiving the slidable knot 120 at least partially therein thatterminates in a platform 114 within the toggle body 100 that does notallow passage of the slidable knot. The second passage includes a lowerportion having an oval shape for allowing both legs of the locking loopto pass therethrough side by side and out the passage. A particularlypreferred knot is a 4-throw uni knot. However, other slidable knots 120may be used, as desired. Further, the second passage oval portion issized to allow movement of at least a portion of the working suture 115to be pulled therein in response to tension on the locking cord. Theworking suture 115 is preferably a braided multistrand suture having acompressible cross-sectional area that reduces by at least about 25%when the locking loop is tightened during use. The working suture 115can be a round and/or braided No. 2 suture in some embodiments. Othersize and type sutures may be used.

As also shown in FIGS. 1I and 1K, after the sliding knot 120 istightened, and the working suture is drawn at least partly into theslot, the preferential point of failure in the locking loop 116 (such asthe break knot or nick described above) breaks, leaving free tail at 123on the locking loop, a distance above the sliding knot, while the restof the proximal portion of the suture lock 124 can be discarded. In someexamples, a more proximal portion of the suture lock is secured to acartridge, so that a physician may cause the suture lock to break asshown by pulling on the cartridge itself, as further described below. Inan example, the preferential point of failure is designed to allowtightening of the locking loop 118 onto the working suture 115 beforethe failure occurs. For example, the locking loop and the preferentialpoint of failure may be configured for breaking under a pull strength inthe range of 3-10 pounds of force, more preferably, 5-7 pounds of force,or more or less as desired. The pull strength needed to tighten thelocking loop 118 onto the working suture may be less than the pullstrength needed for breaking the preferential point of failure in someexamples by, for example, an amount in the range of 0.5 to 3 pounds, or0.75 to 2 pounds, or about 1 pound.

In some preferred embodiments, the above-described anchor does notfunction alone. Instead it is part of a pre-strung array of anchorshaving a common serially disposed working suture 115 therethrough. FIG.2A illustrates a pre-strung array 201. Each anchor 200 can be implantedsequentially within the array, then the working suture section extendingfrom the just implanted anchor to the just previously implanted anchorcan be tensioned, then locked at the just implanted anchor so that asuture stitch between the two anchors provides force against the tendonto hold it in place much like a single sewn stitch. With the array,multiple continuous stitches can be formed similar to a sewn seam.

In FIG. 2A a pre-strung array 201 of individual anchors 200 is depicted.The anchors 200 may be similar in form and function to the anchor 100described herein. The shown array has four anchors 200 as arepresentative chain. It is believed chains of 4 to 12 anchors would beuseful in tendon repair procedures such as rotator cuff repair. Oneparticular embodiment includes 8 anchors in an array. As depicted inFIG. 2A, the way in which the working suture 115 is pre-threaded throughthe series of anchors 200 is important to assure that they will toggleas desired and tension to form the stitch when the suture is tightened.The illustration shows the first anchor 202 to be implanted followed bythe second anchor 204, then the third anchor 206 and finally the fourthanchor 208. With this order of implantation understood, the workingsuture 115 has been pre-threaded down through the top of the proximalhole 210 and back up through the distal hole 211 of the first anchor202. The working suture 115 then continues to the second anchor 204where it is threaded down through the proximal hole 212 and back upthrough the distal hole 213 of the second anchor 204. The working suture115 then continues to the third anchor 206 where it enters the top ofthe proximal hole 214 and back up the distal hole 215 of the thirdanchor 206. The working suture then continues to the fourth anchor 208where it enters the top of the proximal hole 216 and passes up throughthe bottom of distal hole 217 of the fourth anchor 208. If the arraywere more than four anchors, the pre-threading would continue asdescribed for each subsequent anchor.

FIG. 2B is a cross sectional view of the array of FIG. 2A which moreclearly shows the threading of the working suture 115 within the anchors200 in the array 201. The way in which the locking suture 116 isdisposed in the middle passage is also shown for each anchor 200 asdescribed above with each locking loop 118 independent for each anchor.The locking suture 116 can have a preferential point of failure so thatit can be tightened then broken off above the slidable knot. This can beaccomplished by tying a break knot, or making a nick in, in the freetail of the locking loop just above the slidable knot, as furtherillustrated in FIGS. 1H to 1K, above. In some preferred embodiments theslidable knot is a 4-throw uni knot and the break knot is in the freetail just above the uni knot. The suture lock may be designed to breakat a desired tension with the slidable knot in place sufficient to lockthe working suture.

To create an implanted serial array of tensioned and independentlylocked anchor to anchor suture stitches for attaching a tendon to bone,a surgeon would begin with the pre-strung array 201 described in FIG. 2Aand 2B. The first anchor 202 would be implanted through the tendon intoa formed bone hole and the working suture locked. The second anchor 204would then be implanted in close proximity to the first anchor 202,preferably less than 7 mm away. The second anchor is toggled and theworking suture tensioned at the same time by pulling on the workingsuture 115 that exits the distal hole 213 of the second anchor 204.Tension at this location not only toggles the second anchor 204 but alsotightens the working suture 115 going back to the first anchor 202 toform the tensioned stitch holding the tendon against the footprint. Thesecond anchor 204 is then locked so that the stitch remains tensionedand is isolated or independent of other stitches. The process isrepeated for the third anchor 206 and fourth anchor 208 or more. In onepreferred array, eight anchors are implanted and 7 tensioned and lockedstitches in a continuous row are formed. Further, in a rotator cuffrepair, multiple arrays can be implanted such as one array extendingacross the tendon in the medial portion of the footprint and a secondarray more lateral to the medial position.

One preferred anchor delivery device 300 for transtendinous implantationof individual anchors in an array is depicted in FIG. 3A. The deliverydevice 300 is particularly useful to implant anchors disclosed hereinand detailed below with respect to FIGS. 1A-1K and the disclosed arrayin FIGS. 2A-2B.

FIGS. 3A-3C are perspective views of an example anchor delivery devicein several configurations, and FIGS. 3D-3F are close up views of thedistal end of the anchor delivery device corresponding to FIGS. 3A-3C.Starting with FIG. 3A, the delivery device 300 can be a gun-likecomponent that has a proximal housing 310 that includes a pistol griptype handle 311 and trigger 312 that moves from a spring retainedreleased position to an engaged position upon squeezing and holding thetrigger (as further illustrated below). The trigger 312 is linked tomoveable internal features within the proximal housing 310 to providedesired functions during implantation described below.

The delivery device 300 includes an elongate tube 306 extending distallyfrom the proximal housing 310. As shown in the close-up view of FIG. 3D,the elongate tube 306 includes a longitudinal slot 307 over its lengthfor receiving sutures therethrough as anchors are passed through thecentral lumen of the tube.

FIG. 3A also shows that the proximal housing 310 is associated with abone punch having a distal punch head 322 and a proximal punch head 323.The proximal punch head 323 has a tapping surface 324 at its proximalside. Combined elements 322 and 323 form a punch head assembly. Asillustrated in FIG. 3D (which corresponds to the configuration of FIG.3A), the bone punch also includes a punch pin 320 having a tapered point321 adapted for probing through the tendon and/or grabbing the tendon toaid positioning. Positioning may include positioning the tendon in itsoriginal footprint, for tendons that are detached. In some examples,positioning as a separate step may be omitted or limited, such as whenrepairing a partial tear, such as a partial thickness articular sidetear or combination of full thickness and articular partial thicknesstears. A tendon can be considered positioned at a location for securingto bone either by virtue of having placed a fully torn or detachedtendon at a location, such as its original footprint, where it can bere-attached, or, with a partial tear, when the tendon is located where aphysician desired to have it when applying anchors to repair orotherwise address the partial tear.

The punch pin 320 and tip are configured for being pounded into bone tocreate a bone hole; the tapered point 321 is also used in some methodsdisclosed herein to engage and push against the proximal end of ananchor. The punch pin 320 extends through the proximal housing 310 andthe elongate tube 306. The punch pin 320 is affixed to the proximalpunch head 323 and is slidable within the distal punch head 322. Thedistal punch head 322 snap latches to the proximal housing 310 of thedelivery device. The proximal punch head 323 and distal punch head 322are connected by a spring-loaded mechanism that holds the punch pin 320in a fully extended position when the proximal punch head 323 is pushedagainst the distal punch head 322 and latched. When the proximal punchhead 323 is released from close connection with the distal punch head322, the spring loading causes the punch pin 320 to withdraw proximallyto a partially retracted position with only a short distal portion ofthe punch pin 320 extending beyond the elongate tube 306 for use inprobing a potential implant site. Such a configuration of the implanttool is shown in FIGS. 3A and 3D, where the punch pin 320 is the onlypiece extending from the distal tip of the elongate tube 306, the distalpunch head 322 is latched to the proximal housing 310, and the proximalpunch head 323 is not latched to the distal punch head 322. Alsoincluded on the proximal housing 310 is a receiver 398 for receiving amagazine that carries cartridges which hold individual anchors of thearray to be implanted, as is illustrated in FIG. 4A, below.

FIGS. 3B and corresponding FIG. 3E show another configuration of thedelivery device 300. Starting with FIG. 3B, it can be seen that thetrigger 312 remains in a relaxed position and is not depressed(similarly to FIG. 3A). The proximal punch head 323 is now latched tothe distal punch head 322. Latching together of the punch head causesthe distal end of the punch pin 320 to extend further from the distalend of the elongate tube 306, as shown in FIG. 3E. Now an additionalelement can be seen, in that the elongate tube 306 has an anchordelivery tube 330 disposed therein. The action of latching together theproximal punch head 323 with the distal punch head 322 advances theanchor delivery tube 330 distally, and forces a distal portion of theanchor delivery tube 330 past the distal end of the elongate tube 306.The anchor delivery tube 330 also has a longitudinal slot 331 alignedwith the longitudinal slot 307 of the elongate tube for passing a suturetherethrough. With the anchor delivery device 300 configured as shown inFIGS. 3B and 3E, the device is ready for a surgeon to pound or tap thetapping surface 324, such as with a surgical mallet, to force the punchpin 320 and its tip 321 into bone to create a bone hole.

FIGS. 3C and 3F show a next configuration of the delivery device. Here,the distal punch head 322 is no longer engaged with the proximal housing310, and the proximal and distal punch heads 323, 322, are not latchedtogether. The disengagement of the distal punch head 322 and housing310, and disengagement of the proximal and distal punch heads 323, 322,is caused by actuation of the trigger 311, as further discussed below.As described in the method illustration of FIGS. 6A-6G, below, thisconfiguration would arise after a bone hole is created, and is used tointroduce an anchor/suture into the anchor delivery tube for implant. Tofacilitate such a step in the procedure, a portion of the anchordelivery tube 330 referred to as the nub 332 remains extended from thedistal end of the elongate tube 306, as shown by FIG. 3F. With the bonepunch retracted or removed, the anchor delivery tube 330 now defines anopen lumen 333 to allow an anchor to be introduced and passedtherethrough with the aid of the re-inserted bone punch, as detailedbelow. As also highlighted in FIG. 3F, optionally, the distal end of theelongate tube 306 may be tapered as shown at 308. The taper 308, in someexamples, provides the elongate tube 306 with a blunt distal tip thatcan be used to maintain force against the outside of a tendon duringmanipulation of an anchor and/or tensioning of a stitch between twoanchors.

At a high level, the procedure may be understood as follows. With theanchor delivery device 300 in the configuration shown in FIGS. 3A/3D,the physician may probe the surgical site to identify a location wherean anchor is to be implanted. Once the desired location is identified,the physician applies force to the tapping surface 324 of the bone punchto force the bone punch through the tendon and to create a bone holeusing the distal tip 321 of the punch pin 320. As the physician advancesthe bone punch in this manner, the proximal and distal punch heads 323,322 will become latched together to form the configuration as shown inFIGS. 3B/3E. The same action of advancing the bone punch relative to theelongate tube also advances the anchor delivery tube 330 and nub 332beyond the distal end of the elongate tube 306. Next, the trigger 311 isactuated to release the bone punch, pushing the bone punch in a proximaldirection to create the configuration as shown in FIGS. 3C/3F. Theimplant tool 300 is held in position, using the nub 332 to maintainregistration with the formed bone hole. In some examples, a portion ofthe nub will be inserted into the bone hole. An anchor is thenintroduced into the anchor delivery tube 330 and passed down the lumen333 thereof to the distal end, with force applied to advance the anchorusing the bone punch assembly. Complete insertion of the anchor can beconfirmed by maintaining pressure against the tendon to hold the nub 332in the desired registration relative to the bone hole, and pushing theproximal punch head 323 in the distal direction until the distal punchhead 322 latches with the proximal housing 310 and the proximal punchhead 323 latches with the distal punch head 322. Now the trigger 311will again be actuated, however, due to mechanisms that will beexplained below, this second actuation of the trigger after insertion ofthe anchor will apply positive retraction force, along with springforce, to retract the anchor delivery tube 330 and nub 332 into thedistal end of the elongate tube 306, as well as retracting the bonepunch. With the nub retracted, the physician can manipulate toggling ofthe anchor using the working suture without the nub 332 possiblydamaging the working suture, while force can be maintained against thetendon and bone by pressing the distal tip of the elongated tube 306against the tendon. After toggling the anchor, the delivery tool 300 ispulled back from the implant position and the suture lock is secured bypulling on the suture lock cord. If the anchor is the second or asubsequent anchor in a series, the physician may tighten the workingsuture to form a stitch while keeping pressure against the tendon withthe elongated tube 306 prior to moving the delivery device to a nextposition. The delivery device is then reset and the configuration ofFIG. 3A/3D is again assumed.

Turning now to the detailed mechanics of an illustrative example shownin the drawings, FIGS. 3G-3I are partial cut-away views of the anchordelivery device in several configurations. FIG. 3G generally correspondsto the configuration of FIGS. 3A/3D, in which the distal punch head 322is latched to the proximal housing 310, and the proximal punch head 323is not latched against the distal punch head, as can be confirmed in thedrawing by noting that punch head spring 325 is in an extended position.A nub coupler bar 355 is illustrated, and is pushed forward by theproximal punch head via proximal punch head pin 356, having a ridgethereon to interact with the nub coupler bar 355. The device contains aslide stop 350 and an ejector 352. The ejector 352 is in turn secured toa trigger coupler 313 that is pivotably attached at one end to thetrigger 312 and at its other end to the ejector 352. The ejector 352, atits own proximal end in the configuration shown, rests against thedistal punch head 322. The anchor delivery tube is connected at itsproximal end to a nub sub coupler 340 which is itself spring loaded bynub spring 343 relative to the proximal housing 310. As noted withrespect to FIG. 3D, in this configuration the anchor delivery tube nubis retracted into the elongate tube, meaning that the nub spring 343 isin a relaxed state, as shown.

FIG. 3H corresponds to the configuration of FIGS. 3B/3E, in which thedistal punch head 322 is latched to the proximal housing 310, and theproximal punch head 323 is now latched to the distal punch head 322, ascan be confirmed in the drawing by noting that punch head spring 325 isnow compressed. The same action of pushing the proximal punch head 323to latch with the distal punch head 322 also pushes the nub coupler bar355 distally, in turn pushing the nub sub coupler 340 and anchordelivery tube in a distal direction, compressing the nub spring 343 andadvancing the anchor delivery tube so that the nub extends from thedistal end of the elongate shaft, as shown by FIG. 3E. This movementalso changes the juxtaposition of the slide stop 350 and the nub subcoupler 340, which, as can be seen, are now positioned so that theproximal edge of the nub sub coupler 340 is distal of an upper portionof the slide stop 350.

FIG. 3I shows the use of the trigger 312 to force a change ofconfiguration from that of FIGS. 3B/3E to that of FIGS. 3C/3F. Here, thetrigger 312 is squeezed against the grip 311. The trigger coupler 313forces the ejector 352 to move proximally, overcoming the latch force ofthe proximal and distal punch heads 323, 322 relative to the housing 310and disengaging a latch coupling the proximal and distal punch heads323, 322 to each other (see FIG. 3R, below), forcing retraction of thebone punch. However, the nub 332 is not retracted into the elongate tube306 because the slide stop 350 engages with the nub sub coupler 340,blocking it from moving in the proximal direction. The nub spring 343stays compressed.

FIG. 3J shows in a closer view, taken from a rear angle as a partialcut-away view of the proximal housing. Here it can be seen that the nubsub coupler 340 abuts against the slide stop 350 at location 345. Theslide stop 350 is carried on a pin 357, to allow lateral movement aswill be further noted below. The pin 357 carries a slide stop spring 359that pushes the slide stop 350 laterally toward the position shown inFIG. 3J. An additional function of the slide stop 350 is illustrated inFIG. 3K, which provides another angle to view the partial cut-away (withthe slide stop spring 359 omitted). Here, the slide stop 350 includes anextension at 351 which is the part that will abut against the nub subcoupler 340 in the step shown in FIG. 3I/3J. Also visible is a ramp 353on the ejector 352 which will push against the extension 351 to preventan ejector hook 354 from engaging with a corresponding nub sub couplerhook 346 by pressing the ejector 352 down. As can be seen, the slidestop 350 in this configuration prevents retraction of the nub bylimiting the movement of the nub sub coupler 340 in the proximaldirection and also preventing engagement of the ejector hook 354 withthe nub sub coupler hook 346.

FIGS. 3L-3N are partial cut-away views further illustrating theinteraction of internal components of the anchor delivery device. FIG.3L illustrates decoupling of the slide stop 350 from the nub sub coupler340 and the ejector 352. A plunger control arm 385, which is inserted asshown below in FIGS. 4A-4D, pushes the slide stop laterally so that thenub sub coupler 340 cannot engage with the extension 351, and also movesthe slide stop along the pin 357 so that the ejector 352 no longerpresses against the extension 351 when moved in a proximal direction.The slide stop spring 359 is thus compressed, and remains so until thenub sub coupler 340 is again advanced when pounded to create the nextbone hole. In an alternative arrangement, decoupling of the slide stop350 from the nub sub coupler 340 may be achieved by having item 385coupled to a switch or lever on the housing, rather than using theplunger action, if desired. The position of the slide stop spring 359 isillustrative; other configurations and positions may be used.

The movement of the slide stop 350 allows a different interaction tooccur when the trigger is subsequently pulled, as highlighted in FIG.3M. Now, when the trigger is squeezed, the slide stop is no longerblocking movement of other parts, and so the slide stop is omitted fromthe view of FIG. 3M. The assembly remains extended until triggeractuation even with the slide stop moved laterally due to the latchingof the proximal and distal punch heads to one another and latching ofthe distal punch head to the proximal housing. Here, it can be seen thatthe proximal end of the nub sub coupler 340 is free to move proximally.Moreover, positive retraction force can be applied by the ejector 352when it is forced in the proximal direction by the trigger, because theejector hook 354 can now engage with the corresponding nub sub couplerhook 346. To ensure the hooks 346 and 354 interact, a ramp 358 on theunderside of the ejector 352 presses against the plunger control arm385. The resulting action is shown by the view in FIG. 3N, which showshow the nub sub coupler 340 moves past the slide stop 350, allowingretraction of the nub when desired, using force applied via the triggeractuation as well as force applied by the nub spring 343.

FIG. 3Q is a partial cut-away view of the anchor delivery device duringa second actuation of the trigger. Here, the trigger 312 is squeezedagainst the grip 311, and the trigger bar 313 forces the ejector 352 ina proximal direction, unlatching the distal punch head 322 from theproximal housing 310. With the slide stop moved laterally out of theway, the nub sub coupler 340 is forced in a proximal direction as well,under the positive force applied by the trigger 311 via trigger bar 313,ejector 352, and hooks 354, 346 (FIG. 3M). By positive force, what ismeant is that more than the spring force is being applied, such as bythe mechanical linkage of the trigger 311, trigger bar 313, ejector 352and hooks 354, 346. In addition, the nub spring 343 also provides forceto move the nub proximally and will hold the nub in the retractedposition inside the elongate tube 306 until the nub is used again forplacement of another anchor.

FIGS. 3P and 3Q depict features of an illustrative anchor delivery tube.The anchor delivery tube 330, in this example, has a slot at 331 throughwhich sutures as well as the suture lock cord can pass during use. Aninner lumen is defined as shown at 333, through which anchors can pass,as well as the bone punch. If desired, the lower surface of the anchordelivery tube 330 may be stamped or otherwise formed with an indentationor internal trough or channel, as shown at 335, to accommodate a suture336 passing on the lower side of the anchor delivery tube 330. Suchstamping may not be necessary in some examples, depending on the size ofsutures used and how closely the features of the anchor and the anchordelivery tube lumen 333 line up. The proximal end of the anchor deliverytube may be formed with, or may have added thereto, additional materialshown at 337 for securing within the proximal housing 310.

In an alternative configuration, the anchor delivery tube may bereplaced by a push wire coupled to a relatively short nub portion havinga slotted cylindrical shape. The nub portion may have a length of 3-5centimeters, for example, such that a portion thereof can extend fromwithin the lumen of the elongate tube 306 without entirely exiting theelongate tube. The push wire can then extend up the elongate tube to theproximal housing, where it would then be physically coupled to the nubsub coupler 340. Thus a full-length anchor delivery tube may be replacedwith a shorter nub portion, if desired. The push wire (as well as theanchor delivery tube) may be pushed in the distal direction when thebone punch is advanced at the proximal end thereof (by including apusher or linkage attached to the push wire or the nub sub coupler forexample) if desired, or at the distal end thereof (by providing ashoulder for example toward the distal end of the bone punch to interactwith the nub and/or a short anchor delivery tube).

FIG. 3R illustrates coupling of the bone punch assembly. In FIG. 3R, theejector 352 is shown, including its proximal end having an angledsurface at 347. The angled surface at 347 is aligned with latch arm 348,which is itself part of the proximal punch head. The latch arm 348 isshown engaged with spring base 349, which is part of the distal punchhead, and carries the punch head spring 325. As can then be understood,as the trigger is depressed, the ejector 352 will move in a proximaldirection, engaging latch arm 348 and pushing the latch arm 348 outward,disengaging the latch arm 348 from the spring base 349, releasing theproximal punch head from the distal punch head. In some examples, thephysician may use this maneuver without causing the distal punch head todisengage from the housing, such as by lightly pulling the trigger,causing the proximal punch head to release from the distal punch headand thereby retracting the punch pin and pointed distal tip. As aresult, this feature allows the physician to readily control how far thedistal tip of the punch pin extends beyond the nub and/or the distal endof the outer tube of the anchor delivery device.

FIGS. 4A-4D illustrate features of a plunger for delivering anchors fromindividual cartridges to the delivery device and a magazine for holdingcartridges on the anchor delivery device. Starting with FIG. 4A, thedelivery device is generally shown at 300 with the proximal housing at310. On one side of the proximal housing is a receiver 370 into which aplunger 380 can be slidably placed and retained. The top of the receiverincludes a slot 372 for receiving a cartridge 392 that carries an anchorto be implanted. The cartridge 392 can be seen to have at least firstand second ends of a working suture 393 extending therefrom.

The delivery device is shown relative to a patient 400 having a patientportal 402, which may be for example a shoulder portal that is formedfor performing arthroscopic surgery. In the example shown, the removedcartridge 392 is shown with the working suture 393 extending on eitherside thereof. The physician may pull the cartridge away from themagazine and the delivery device, as well as the portal 402, in order tofloss the working suture 393 so that an amount of slack is available oneither side of the anchor contained in the cartridge 392. The purpose ofthis maneuver is to ensure that as the anchor is advanced through thedelivery device and into the patient, there will be enough slack to makethis passage easy. That is, while it is possible to floss the suturethrough the anchor during delivery and implantation, it may bepreferable to generate slack before the implantation to make advancementof the anchor into position relatively easier. Once the anchor ispositioned, the extra slack can be taken out as the physician tensionsthe working suture to create a stitch between the anchor being toggledand a previously placed anchor.

Opposite the plunger 380 is a magazine 390 that can be releasablysecured to the proximal housing 310 and carries a plurality ofcartridges 391. A cartridge ejector is shown at 394 for ejectingcartridges 391/392 one at a time. The magazine is shown with 7cartridges 391 therein, the 8^(th) cartridge 392 having already beenejected. In the example shown, at least one additional cartridge hasalready been ejected and used, since the working suture 393 can be seento extend into the elongate tube 306 and into the patient portal 402. Itwill be understood as well that the magazine is carried on receiver 398(FIG. 3A). Greater detail regarding the magazine and its use can befound in U.S. patent application Ser. No. 17/551,811, filed Dec. 15,2021 and titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTUREANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, thedisclosure of which is incorporated herein by reference.

More details of the plunger and receiver are shown in FIGS. 4B and 4C.Starting with FIG. 4B, the plunger itself is shown at 380, in anextended position relative to a receiver 370. The slot 372 can beobserved in this top view of the proximal housing 310. When a cartridge(not shown) is placed in the slot 372, the plunger can be depressed asshown in FIG. 4C. Doing so laterally transfers the anchor from thecartridge into the bore through the length of the delivery device. Theanchor is then ready to be inserted by advancing the bone punch throughthe proximal housing and down the anchor delivery lumen. Referring backto FIG. 4B, the anchor is carried in a cartridge 392 such that when thecartridge 392 is inserted into slot 372, the anchor generally lies alongline 374, while the midline of the anchor delivery tube is showngenerally at 376. The plunger prepares the anchor for delivery bypushing the anchor laterally to the midline of the anchor delivery tubeat 376, and holds the anchor in position until the bone punch isadvanced to push the anchor down the anchor delivery tube.

In addition, the plunger being depressed causes the changes inconfiguration previously described within the proximal housing. Inparticular, in the illustrative example that is shown herein, depressingthe plunger moves the slide stop 350 discussed above laterally out ofthe way of the nub sub coupler 340 and out of the way of the ejector352, allowing the retraction of the nub after the anchor has beeninserted. In some examples, the anchor delivery device will not allowthe plunger to be actuated from its extended position to its depressedposition while the bone punch is extended down the lumen of the anchordelivery tube. That is, until the bone punch has been retracted after aphysician has first actuated the trigger, the plunger cannot bedepressed fully in some examples.

FIG. 4D shows the plunger in isolation. Here, the plunger 380 can beseen to include an anchor pusher 384 including an anchor platform 383that sits under the anchor, and matching bars 382 that extend intomatching slots of the cartridge. The plunger control arm 385 is alsoshown. The control arm 385 is the element discussed previously thatmoves the slide stop 350 laterally to allow retraction of the anchordelivery tube and nub after the anchor is fully implanted. The controlarm 385 also serves to push the ejector 352 upwards when in position toensure coupling of the ejector (and hence the trigger) to the nub subcoupler that in turn attaches to the anchor delivery tube and nub. Guidearms 381 are used to guide the plunger 380 as it slides in and out ofthe receiver 370.

Referring back to FIG. 3M, the plunger latch 386 (not visible in FIG.4D) is carried on the control arm 385. The plunger latch 386, when theplunger is fully inserted, rests against plunger catch 387 to preventremoval of the plunger 380. When the ejector 352 is used to pull backthe nub sub coupler 340, the bottom of the ejector 352 pushes thecontrol arm 385 in a proximal direction and, as shown in FIG. 3M, allowsthe plunger latch 386 to be released once the nub and bone punch havebeen at least initially retracted. The body of the plunger 380 mayconnect to the anchor pusher 384, in some examples, with a wave spring(not shown, but residing inside the body of the plunger 380) that allowsovertravel to ensure latching of the control arm 385 and plunger latch386. When the plunger latch 386 is released, the wave spring (or anotherspring, if provided) pushes the plunger back to its extended position.The slide stop may also move back to its original position under springpressure.

In an alternative configuration, the control arm 385 may not be part ofthe plunger, and may instead be coupled to a switch or lever on theproximal housing, allowing the physician to determine the mode oftrigger operation without using a plunger. To this end, item 399 in FIG.4A may be used as a switch or button to control position of the slidestop, for example.

In another alternative, the slot 372 may be placed directly in line withthe central axis 376 (FIG. 4B) of the anchor delivery tube, and ratherthan lateral movement out of the cartridge, an anchor may be placed inposition for advancement down the anchor delivery tube directly. As anexample, the slot 372 may instead be positioned at location 372A in FIG.4B, and the plunger 380 and receiver 370 could then be omitted. Forexample, a physician may remove a pre-strung anchor from sterilepackaging and directly place the anchor into a centrally positionedslot. Alternatively, a physician could place the anchor in a centralslot such as that at 372A by insertion of the cartridge. While someexamples herein show a cartridge configured for lateral removal of ananchor, in an alternative in which the cartridge is inserted in acentrally located slot (372A), a cartridge as shown in FIG. 5A/5B mayinstead have an opening as shown at 527 that allows removal of theanchor in an axial direction (such an arrangement may omit the boss 512and/or has the working suture positioned on top of the boss 512 to allowaxial movement). Other alternatives can be used as well.

To recap regarding the implantation procedure, the physician uses theconfiguration of FIG. 3A to probe the surgical site and identifies alocation at which an anchor is to be placed. The physician then taps orpounds on the proximal punch head which causes the bone punch toadvance. As the bone punch is advanced, the proximal punch head latcheswith the distal punch head, assuming the configuration of FIG. 3B, alsoforcing the nub distal of the distal end of the outer elongate tube. Asthe tapping force is applied, each of the bone punch pin and tip extendthrough the tendon and into bone, and the nub is pushed intoregistration with the bone hole, at least partly engaging the nub withthe bone hole. While this order of operations is useful in one example,the steps may be reordered as desired, such as by latching the punchhead together prior to probing, if desired.

The physician then pulls the trigger a first time. Because the plungeris not engaged/depressed at this time, the trigger actuation results inretraction of the bone punch, but not the nub at the end of the anchordelivery tube. A cartridge is taken from the magazine, extended out fromthe magazine to create slack on either side of the cartridge in theworking suture, and inserted into the slot for receiving cartridges onthe delivery device housing. Before or after cartridge placement, thebone punch is retracted to a position that places the distal tip of thebone punch proximal of the location of the plunger, allowing the plungerto now be depressed. With the cartridge in place and bone punchretracted, the plunger is used to push the anchor into alignment withthe anchor delivery tube. The bone punch is then advanced to push theanchor to and out of the distal tip of the anchor delivery tube. Fullextension of the bone punch is demonstrated by latching the proximalpunch head to the distal punch head, which is itself latched to theproximal housing of the delivery tool.

The physician will again squeeze the trigger. This second actuation ofthe trigger occurs with the plunger fully inserted, meaning thatactuation of the trigger retracts the bone punch as well as the anchordelivery tube, as the plunger insertion will have moved the slide stopout of the path of the nub sub coupler and forces engagement of theejector thereto, actively pulling the nub as well as the bone punch outof the bone hole. The same trigger action also releases the plunger asthe ejector pushes the control bar to release the plunger under springaction. What remains, as discussed in FIGS. 6A-6I, are the steps ofcompleting the toggling of the anchor and tensioning the working suture,followed by securing the suture lock, before moving on to the nextanchor. Though not shown, the anchor delivery tool may optionallyinclude a punch stop to prevent the bone punch from being removedentirely from the device.

FIGS. 5A-5D illustrate a cartridge for holding a toggle anchor. Startingwith FIG. 5A, a cartridge 500 is illustrated with a handle 502 adaptedfor grasping by the user/physician. An inner holder is shown at 510, andis surrounded by a cover 520. The inner holder 510 secures an anchor 100between an upper anchor support 511 and a boss 512. In the configurationshown in FIG. 5A, the cartridge is “closed” in that the anchor 100cannot be removed.

FIG. 5B shows the cover 520 raised to an “open” position in which theanchor 100 is no longer secured by the cover 520. The cover defines twochannels at 522, 524. First channel 522 provides a path for the workingsuture out of the cartridge 500, and second channel 524 provides a pathfor the suture lock, as will be further detailed below. The cover may bespring biased to the closed position, if desired, to prevent inadvertentremoval of the anchor 100 during handling. Alternatively, the cover caninclude detents to hold the cover in a closed position until pressure isapplied during insertion. In addition, the upper anchor support 511 andboss 512 are spaced so that the anchor 100 is held in position againstfalling out.

As noted previously, an alternative design may have the inner holder 510open in alignment with slot 527 to allow anchor removal in an axial,rather than lateral direction. For such an alternative, in an example,the upper anchor support 511 and boss 512 would be positioned higher upon the inner holder, such that the anchor 100 would be held at position516 as shown in FIG. 5B.

FIG. 5C shows the cartridge 500 in the closed position again with thecover down. The working suture 530 is now shown passing through firstchannel 522. The suture lock is shown as well, with the free end 540 ofthe suture lock passing through second channel 524 and the locking loopshown at 542. As can be seen, the boss 512 holds the working suture 530away from the underside of the anchor 510, making flossing of theworking suture easier prior to release of the anchor 510 from thecartridge. That is, because the bottom side of the anchor 510 mayinclude a channel that makes flossing of the working suture therethroughmore difficult, keeping the working suture 530 away from the bottom sideof the anchor 100 may make flossing easier. Also, when the workingsuture 530 is pulled close to the bottom side of the anchor 100, thepath that must be navigated when flossing includes first and second nearninety degree turns, increasing friction as the working suture 530 isflossed. Therefore, the boss 512 can be seen to make flossing easier insome examples. In other examples, the boss 512 may be designed so thatthe working suture does not wrap around it, and instead a simple supporton the bottom side of the anchor 100 may be provided, with the workingsuture then resting between the support and the bottom side of theanchor. It may also be noted that having the working suture placed asshown may aid in retaining the anchor in place until it is ejected bythe insertion of the plunger in the examples shown above.

FIG. 5D shows the back side of the cartridge 500. Of note here, the freeend 540 of the locking loop 542 passes into a channel and then to aspool 514. In an example, the free end 540 is attached to the spool 514,such as by a knot, so that the free end can be pulled a select distance(10 to 20 cm, for example) before reaching a point where it can nolonger unspool. When the physician seeks to use the locking loop, thecartridge 500 can be grasped and pulled until the spool runs out. Thephysician can then pull on the cartridge and therefore on the free endof the locking loop until the locking loop breaks at the break knot (orother preferential point of failure), as described below and above. Theresult is that the physician can manually grasp the cartridge to easilylock the locking loop and break the free end of the locking loop withoutneeding a special tool and/or without needing to attempt to grasp thethin cord of the free end of the locking loop. It can be observed thatthe spool 514 includes inner features 515 allowing a tool to be insertedand twisted to spool the free end 540 of the locking loop onto the spool514. As with the steps of toggling and/or tensioning a stitch, thedistal end of the anchor delivery tool may be used to apply exteriorpressure on the tendon as the locking loop is tightened and the free endis broken off.

FIG. 5E illustrates interaction of a cartridge of FIGS. 5A-5D with aplunger as in FIGS. 4A-4D. The rest of the proximal housing of theanchor delivery tool is omitted, but it may be understood that insertionof the cartridge 500 into the slot for receiving the cartridge has nowraised the cover 520 to an open position. The plunger is then slid intothe position shown. With the plunger depressed, the anchor pusherstructure 584 passes through the cartridge, with the anchor support 383and matching rails 382 passing through the cartridge. The rails 382 passon either side of the upper anchor supports 511, and ensure that theworking suture is released from the cartridge when the plunger isdepressed. As can also be seen, the control bar 385 is now inserted andperforms the functions of moving the slide stop discussed above.

Additional details regarding an illustrative magazine and its use may befound in U.S. patent application Ser. No. 17/551,811, filed on Dec. 15,2021, and titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTUREANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE., thedisclosure of which is incorporated herein by reference.

It should be noted that the illustrative anchor implantation systemshown is but one example of how the presently disclosed anchor systemmay be implanted. For example, a system that fully withdraws the distalend of the bone punch back to the proximal housing as shown may not benecessary. Separate cartridges for each bone anchor are illustrated inthe implantation system; in other examples, several anchors may bedisposed together in one cartridge in a longitudinal fashion, forexample, for sequential loading. Another anchor delivery tool isdisclosed, for example, in U.S. Provisional Patent Application Ser. No.63/172,629, filed Apr. 8, 2021 and titled DELIVERY DEVICE FOR IMPLANTINGKNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFTTISSUE TO BONE, the disclosure of which is incorporated herein byreference. Rather than lateral release of an anchor from a cartridge, anaxial release may be used. In some examples, a cartridge can be omittedentirely. Any suitable implantation system may be used, as desired.

In FIGS. 6A through 6G, an exemplary method for implanting individualand an array of anchors is depicted. Further, FIGS. 6H and 6I illustrateexample suture stitch arrays as implanted on the surface of a rotatorcuff tendon having anchor to anchor continuous stitches that areindependently tensioned and locked that can result from using thismethod.

Referring first to FIG. 6A, a schematic of select parts of the shoulderrotator cuff 600 is depicted in order to explain the methods ofimplantation. The illustration includes a portion of the humeral head602 shown including an outer cortical shell layer 604 and an innercancellous bone material 606. A tendon, in this case the supraspinatustendon 608 is shown overlaying a portion of the humeral head where isattached to the footprint. The method is a transtendinous or through thetendon repair. The tendon 608 is first positioned in a desired locationfor reattachment to bone in the footprint of original attachment. Thedelivery device of FIGS. 3A-3R, or similar is then utilized to implantthe toggle type suture anchor through the tendon 608. To begin thedelivery device is set as in FIG. 3C with the distal nub 332 extendingfrom the distal end of the implant delivery tube 330 and elongate tube306. The bone punch 320 is fully inserted distally so that it extendsbeyond the distal end of the nub 332 and is locked in place, as is thenub locked in place. The device as configured is positioned on thetendon at the desired anchor placement and pounded in until the distalend of the outer tubular member is in contact with the tendon as shownin FIG. 6A. At this point the nub 332 extends through at least a portionof the cortical shell 604 (in thinner bone the nub 332 can extend intothe cancellous bone 606) and the distal end of the bone punch 320extends deeper into the cancellous bone 606. To achieve the desireddepth of implantation to assure toggling, the bone punch extends beyondthe elongate tube 306 distal end a distance of greater than or equal toabout 20 mm. Further, to assure nub registration with the bone hole, thenub portion 332 extends beyond the elongate tube 306 distal end adistance of about 6 to about 10 mm.

As depicted in FIG. 6B, the bone punch 320 is then retracted whilemaintaining the elongate tube 306 and nub portion 332 in place, with thenub portion 332 providing registration with the formed hole in the bone.Absent such registration with the bone hole by the nub portion 332, thelocation under the tendon would be lost and it would be very difficultto feed an anchor through the tendon which would tend to fill the holethrough which the bone punch traveled. In some examples, as describedabove, this step of the method may be performed by depressing a triggeron an implant tool where the implant tool is configured to maintain thenub portion 332 extended under certain circumstances (for example, withthe slide stop in place) while applying a positive retraction force tothe bone punch 320.

The first toggle type anchor is transferred or inserted into theproximal portion of the anchor delivery tube inside the elongate tube306. As shown in FIG. 6C, the bone punch 320 is then reinserted into thelumen of the anchor delivery tube and advanced distally. As shown inFIG. 6C, the toggle body 100 of the anchor is pushed out the distal endby the bone punch 320. The bone punch 320 continues to be advanced inthe distal direction to its original depth to push the toggle body 100into the bone. It has been found that pushing the proximal end of theanchor deep into the bone with the toggle body 100 having an angleddistal end causes or at least initiates rotation of the toggle body 100.This initial rotation assures continued rotation upon pulling tension onthe working suture 115 outside the body.

As shown in FIG. 6E, the bone punch 320 and nub 332 are then retractedby the application of positive force by the trigger (as shown inexamples above), as well as with spring action. This assures the nub 332does not cut or fray the working suture. The bone hole remains shown inthe drawings. The distal portion of the working suture extending fromthe distal passage is then pulled to complete the toggling of the anchoras aided by the proximal fins on the toggle body. This is shown in FIG.6E. With continued tension on the working suture, the toggle body 100 ispulled toward the inside surface of the cortical shell of the bone asshown in FIG. 6F. To aid this step, the anchor delivery tool distal endmay be pressed against the tendon to provide a counterforce againstpullout during toggling and/or suture tensioning; that is, as the anchoris toggled and the suture is tensioned, the toggle body 100 may reachand press against the cortical shell. Additional counterforce can beapplied in particular in regions of thinner cortical shell, such at theedges or outside of a tear footprint, and/or between the greater andlesser tubricals of the humerus. As depicted in FIG. 6G, once theworking suture 115 is tensioned, the locking suture is tensioned toclose the locking loop 118 around the working suture 115 and fix theworking suture relative to the toggle body 100. In some examples, thelocking suture is broken during this step at the knot which is at orinside the central bore of the anchor 100, thus, FIG. 6G shows only theworking suture extending back into the elongate tube 306.

With implantation of the first anchor, the working suture 115 is simplylocked as it cannot be tensioned to form a stitch until the secondanchor is implant. In some examples, the first anchor in a chain ofanchors can be pre-locked for this purpose; in other examples thesurgeon will lock the first anchor suture lock at the time of implant.Therefore, in preferred methods, the second anchor is implantedrepeating the above steps, except to the extent that the suture lock isdifferently engaged. As the working suture is pulled to toggle theanchor, any loose working suture between the first and second anchors ispulled through to form the tensioned stitch. During suture tensioningthe distal end of the elongate tube 306 can be maintained against theouter surface of the tendon to prevent pullout or even possible bonefracture at the cortical shell. Once properly tensioned, the secondanchor is locked. These steps are repeated for the rest of the anchorsin an array.

As shown in FIGS. 6H and 6I, using the above method and device cancreate a row of continuous stitches that closely spaced, individuallytensioned and tightened. A preferred pattern includes a row of stitchesgenerally perpendicular to the direction of the tendon as shown in FIG.6H. In a rotator cuff repair these would all be placed in a medialportion of the original tendon footprint. In some preferred embodimentsa second row of anchors is also implanted, especially in a rotator cuffrepair. The second row is implanted laterally of the first row and caninclude a zig zag pattern to put some anchors in the lateral portion ofthe original footprint and other anchors lateral of the footprint tohold down edges of the torn tendon. Other configurations are alsopossible depending on the size and shape of the tear. For example, on asmall tear a single zig zag row of stitches could be used as shown inFIG. 6I. Anchors may also be placed to create stitches over attachedportions of the tendon to reinforce the margins/edges of fully orpartially torn tendons.

The preceding provides a relatively complete description of the anchoritself, pre-strung anchor arrays, suture lock, cartridge, magazine, andanchor delivery tool. A range of inventions are thus disclosed, and notall components or parts needs to be used together. For example, thedelivery tool may be configured to for use with other anchors,cartridges, magazines, etc. Likewise, the anchors may be used indifferent configurations with other working suture and suture lockarrangements, other cartridges, magazines and delivery tools. Thus theoverall combination shown can be modified in a variety of ways.Additional features and alternative designs for various components,subassemblies and assemblies may be found in the following patentapplications, each of which is incorporated herein by reference:

U.S. Prov. Pat. App. No. 63/172,564, filed Apr. 8, 2021, titled KNOTLESSMICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICAL ATTACHMENT OF SOFTTISSUE TO BONE, and U.S. patent application Ser. No. 17/551,588, filedDec. 15, 2021, titled KNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYSFOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,613, filed Apr. 8, 2021, titled KNOTLESSMICRO SUTURE ANCHOR ARRAY FOR HIGH DENSITY ANATOMICAL ATTACHMENT OF SOFTTISSUE TO BONE, and U.S. patent application Ser. No. 17/551,728, filedDec. 15, 2021, titled KNOTLESS MICRO SUTURE ANCHOR ARRAY FOR HIGHDENSITY ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,614, filed Apr. 8, 2021, titled METHODFOR CREATING A TENSIONABLE AND LOCKABLE SUTURE ANCHOR ARRAY FORANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patentapplication Ser. No. 17/551,779, filed Dec. 15, 2021, titled METHOD FORCREATING A TENSIONABLE AND LOCKABLE SUTURE ANCHOR ARRAY FOR ANATOMICALATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,629, filed Apr. 8, 2021, titled DELIVERYDEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYSFOR ATTACHMENT OF SOFT TISSUE TO BONE, U.S. Prov. Pat. App. No.63/281,411, filed Nov. 19, 2021, titled DELIVERY DEVICE FOR IMPLANTINGKNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFTTISSUE TO BONE, and U.S. patent application Ser. No. 17/551,811, filedDec. 15, 2021, titled DELIVERY DEVICE FOR IMPLANTING KNOTLESSMICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TOBONE.

U.S. Prov. Pat. App. No. 63/172,624, filed Apr. 8, 2021, titledCARTRIDGE DEVICE FOR SUTURE ANCHOR AND SUTURE MANAGEMENT DURINGIMPLANTATION OF A MICRO SUTURE ANCHOR ARRAY, and U.S. patent applicationSer. No. 17/551,838, filed Dec. 15, 2021, titled CARTRIDGE DEVICE FORSUTURE ANCHOR AND SUTURE MANAGEMENT DURING IMPLANTATION OF A MICROSUTURE ANCHOR ARRAY.

U.S. Prov. Pat. App. No. 63/172,568, filed Apr. 8, 2021, titled LOCKINGSUTURE CONSTRUCT FOR TENSIONED SUTURE TO SUTURE BRIDGES IN ANCHOR ARRAYSFOR ATTACHING SOFT TISSUE TO BONE and U.S. patent application Ser. No.17/551,860, filed Dec. 15, 2021, titled LOCKING SUTURE CONSTRUCT FORTENSIONED SUTURE TO SUTURE STITCHES IN ANCHOR ARRAYS FOR ATTACHING SOFTTISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,630, filed Apr. 8, 2021, titled METHODSFOR TRANSTENDINOUS IMPLANTATION OF KNOTLESS MICRO SUTURE ANCHORS ANDANCHOR ARRAYS, and U.S. patent application Ser. No. 17/551,885, filedDec. 15, 2021, titled METHODS FOR TRANSTENDINOUS IMPLANTATION OFKNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYS.

Each of these non-limiting examples can stand on its own or can becombined in various permutations or combinations with one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments. These embodimentsare also referred to herein as “examples.” Such examples can includeelements in addition to those shown or described. However, the presentinventors also contemplate examples in which only those elements shownor described are provided. Moreover, the present inventors alsocontemplate examples using any combination or permutation of thoseelements shown or described (or one or more aspects thereof), eitherwith respect to a particular example (or one or more aspects thereof),or with respect to other examples (or one or more aspects thereof) shownor described herein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols. In this document, the terms “a” or “an” are used, as is commonin patent documents, to include one or more than one, independent of anyother instances or usages of “at least one” or “one or more.” Moreover,in the claims, the terms “first,” “second,” and “third,” etc. are usedmerely as labels, and are not intended to impose numerical requirementson their objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims.

Also, in the above Detailed Description, various features may be groupedtogether to streamline the disclosure. This should not be interpreted asintending that an unclaimed disclosed feature is essential to any claim.Rather, innovative subject matter may lie in less than all features of aparticular disclosed embodiment. Thus, the following claims are herebyincorporated into the Detailed Description as examples or embodiments,with each claim standing on its own as a separate embodiment, and it iscontemplated that such embodiments can be combined with each other invarious combinations or permutations.

The scope of the protection should be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled.

What is claimed is:
 1. A method for securing soft tissue to bone bycreating a suture array having individually tensioned suture stitchesextending over and compressing the soft tissue between sequentiallyimplanted toggle body bone anchors, the method comprising: providing afirst toggle body having a first end of a working suture affixed theretoand a length of the working suture extending therefrom; implanting thefirst toggle body through the tendon into the bone at a selectedlocation with the length of working suture extending therefrom;providing a second toggle body having at least a first and a second holethrough the toggle body extending from a first longitudinal surface to asecond longitudinal surface of the toggle body, the first hole extendingthrough a distal portion of the toggle body and the second hole througha proximal portion of the toggle body with the length of working sutureextending from the first toggle body passing through the proximal holefrom the first surface to the second surface then through the distalhole from the second surface to the first surface and continuingtherefrom; inserting the second toggle body through the tendon into thebone, distal portion first, at a spaced distance from the first togglebody; and, applying tension to the working suture extending from thedistal hole first surface of the second toggle body to remove slack inthe working suture between the first and second toggle body and form atensioned stitch while the tension also rotates the inserted secondtoggle body into a secured position within the bone.
 2. The method forsecuring soft tissue to bone of claim 1, further comprising: providing athird toggle body having at least a first and a second hole through thethird toggle body extending from a first longitudinal surface to asecond longitudinal surface of the toggle body, the first hole extendingthrough a distal portion of the toggle body and the second hole througha proximal portion of the toggle body with the length of working sutureextending from the second toggle body passing through the proximal holefrom the first surface to the second surface then through the distalhole from the second surface to the first surface and continuingtherefrom; inserting the third toggle body through the tendon into thebone, distal portion first, at a spaced distance from the second togglebody; and applying tension to the working suture extending from thedistal hole first surface of the third toggle body to remove slack inthe working suture between the second and third toggle body and form atensioned stitch while the tension also rotates the inserted thirdtoggle body into a secured position within the bone.
 3. The method forsecuring soft tissue to bone of claim 2, further comprising: providing afourth toggle body having at least a first and a second hole through thetoggle body extending from a first longitudinal surface to a secondlongitudinal surface of the toggle body, the first hole extendingthrough a distal portion of the toggle body and the second hole througha proximal portion of the toggle body with the length of working sutureextending from the third toggle body passing through the proximal holefrom the first surface to the second surface then through the distalhole from the second surface to the first surface and continuingtherefrom; inserting the fourth toggle body through the tendon into thebone, distal portion first, at a spaced distance from the third togglebody; and applying tension to the working suture extending from thedistal hole first surface of the fourth toggle body to remove slack inthe working suture between the third and fourth toggle body and form atensioned stitch while the tension also rotates the inserted fourthtoggle body into a secured position within the bone.
 4. The method forsecuring soft tissue to bone of claim 3, further comprising: providing afifth toggle body having at least a first and a second hole through thetoggle body extending from a first longitudinal surface to a secondlongitudinal surface of the toggle body, the first hole extendingthrough a distal portion of the toggle body and the second hole througha proximal portion of the toggle body with the length of working sutureextending from the fourth toggle body passing through the proximal holefrom the first surface to the second surface then through the distalhole from the second surface to the first surface and continuingtherefrom; inserting the fifth toggle body through the tendon into thebone, distal portion first, at a spaced distance from the fourth togglebody; and applying tension to the working suture extending from thedistal hole first surface of the fifth toggle body to remove slack inthe working suture between the fourth and fifth toggle body and form atensioned stitch while the tension also rotates the inserted fifthtoggle body into a secured position within the bone.
 5. The method forsecuring soft tissue to bone of claim 4, further comprising: providing asixth toggle body having at least a first and a second hole through thetoggle body extending from a first longitudinal surface to a secondlongitudinal surface of the toggle body, the first hole extendingthrough a distal portion of the toggle body and the second hole througha proximal portion of the toggle body with the length of working sutureextending from the fifth toggle body passing through the proximal holefrom the first surface to the second surface then through the distalhole from the second surface to the first surface and continuingtherefrom; inserting the sixth toggle body through the tendon into thebone, distal portion first, at a spaced distance from the fifth togglebody; and applying tension to the working suture extending from thedistal hole first surface of the sixth toggle body to remove slack inthe working suture between the fifth and sixth toggle body and form atensioned stitch while the tension also rotates the inserted sixthtoggle body into a secured position within the bone.
 6. A method forsecuring soft tissue to bone by creating a suture array havingindividually tensioned and locked suture stitches extending over andcompressing the soft tissue between sequentially implanted toggle bodybone anchors, the method comprising: providing a first toggle bodyhaving a first end of a working suture affixed thereto and a length ofthe working suture extending therefrom; implanting the first toggle bodythrough the tendon into the bone at a select location with the length ofworking suture extending therefrom; providing a second toggle bodyhaving at least a first and a second hole through the toggle bodyextending from a first longitudinal surface to a second longitudinalsurface of the toggle body, the first hole extending through a distalportion of the toggle body and the second hole through a proximalportion of the toggle body with the length of working suture extendingfrom the first toggle body passing through the proximal hole from thefirst surface to the second surface then through the distal hole fromthe second surface to the first surface and continuing therefrom, with alocking loop encircling the working suture between the first and secondhole having a first open position that allows sliding of the workingsuture relative to the toggle body and a second closed position thatsecures the working suture relative to the toggle body; inserting thesecond toggle body through the tendon into the bone, distal portionfirst, at a spaced distance from the first toggle body; applying tensionto the working suture extending from the distal hole first surface ofthe second toggle body to remove slack in the working suture between thefirst and second toggle body and form a tensioned first stitch while thetension also rotates the inserted second toggle body into a securedposition within the bone; and then moving the locking loop to the secondclosed position to lock the first stitch.
 7. The method for securingsoft tissue to bone of claim 6, further comprising: providing a thirdtoggle body having at least a first and a second hole through the togglebody extending from a first longitudinal surface to a secondlongitudinal surface of the toggle body, the first hole extendingthrough a distal portion of the toggle body and the second hole througha proximal portion of the toggle body with the length of working sutureextending from the second toggle body passing through the proximal holefrom the first surface to the second surface then through the distalhole from the second surface to the first surface and continuingtherefrom, with a locking loop encircling the working suture between thefirst and second hole having a first open position that allows slidingof the working suture relative to the toggle body and a second closedposition that secures the working suture relative to the toggle body;inserting the third toggle body through the tendon into the bone, distalportion first, at a spaced distance from the second toggle body;applying tension to the working suture extending from the distal holefirst surface of the third toggle body to remove slack in the workingsuture between the second and third toggle body and form a tensionedsecond stitch while the tension also rotates the inserted third togglebody into a secured position within the bone; and then moving thelocking loop to the second closed position to lock the second stitch. 8.The method for securing soft tissue to bone of claim 7, furthercomprising: providing a fourth toggle body having at least a first and asecond hole through the toggle body extending from a first longitudinalsurface to a second longitudinal surface of the toggle body, the firsthole extending through a distal portion of the toggle body and thesecond hole through a proximal portion of the toggle body with thelength of working suture extending from the third toggle body passingthrough the proximal hole from the first surface to the second surfacethen through the distal hole from the second surface to the firstsurface and continuing therefrom, with a locking loop encircling theworking suture between the first and second hole having a first openposition that allows sliding of the working suture relative to thetoggle body and a second closed position that secures the working suturerelative to the toggle body; inserting the fourth toggle body throughthe tendon into the bone, distal portion first, at a spaced distancefrom the third toggle body; applying tension to the working sutureextending from the distal hole first surface of the fourth toggle bodyto remove slack in the working suture between the third and fourthtoggle body and form a tensioned third stitch while the tension alsorotates the inserted fourth toggle body into a secured position withinthe bone, and then moving the locking loop to the second closed positionto lock the third stitch.
 9. The method for securing soft tissue to boneof claim 8, further comprising: providing a fifth toggle body having atleast a first and a second hole through the toggle body extending from afirst longitudinal surface to a second longitudinal surface of thetoggle body, the first hole extending through a distal portion of thetoggle body and the second hole through a proximal portion of the togglebody with the length of working suture extending from the fourth togglebody passing through the proximal hole from the first surface to thesecond surface then through the distal hole from the second surface tothe first surface and continuing therefrom, with a locking loopencircling the working suture between the first and second hole having afirst open position that allows sliding of the working suture relativeto the toggle body and a second closed position that secures the workingsuture relative to the toggle body; inserting the fifth toggle bodythrough the tendon into the bone, distal portion first, at a spaceddistance from the fourth toggle body; applying tension to the workingsuture extending from the distal hole first surface of the fifth togglebody to remove slack in the working suture between the fourth and fifthtoggle body and form a tensioned fourth stitch while the tension alsorotates the inserted fifth toggle body into a secured position withinthe bone; and then moving the locking loop to the second closed positionto lock the fourth stitch.
 10. The method for securing soft tissue tobone of claim 9, further comprising: providing a sixth toggle bodyhaving at least a first and a second hole through the toggle bodyextending from a first longitudinal surface to a second longitudinalsurface of the toggle body, the first hole extending through a distalportion of the toggle body and the second hole through a proximalportion of the toggle body with the length of working suture extendingfrom the fifth toggle body passing through the proximal hole from thefirst surface to the second surface then through the distal hole fromthe second surface to the first surface and continuing therefrom, with alocking loop encircling the working suture between the first and secondhole having a first open position that allows sliding of the workingsuture relative to the toggle body and a second closed position thatsecures the working suture relative to the toggle body; inserting thesixth toggle body through the tendon into the bone, distal portionfirst, at a spaced distance from the fifth toggle body; applying tensionto the working suture extending from the distal hole first surface ofthe sixth toggle body to remove slack in the working suture between thefifth and sixth toggle body and form a tensioned fifth stitch while thetension also rotates the inserted sixth toggle body into a securedposition within the bone; and then moving the locking loop to thesection closed position to lock the fifth stitch.
 11. A method forcreating a serial array of tensioned and independently locked anchor toanchor suture stiches to attach soft tissue to bone, the methodcomprising: providing a first toggle body having a first end of aworking suture affixed thereto and a length of a working sutureextending therefrom; providing a plurality of additional toggle bodies,each having an elongate body portion with a proximal, a middle and adistal passage extending from a top surface to a bottom surface, eachpassage located at spaced intervals along the elongate body portion withthe middle passage between the proximal and distal passage and thelength of working suture serially connecting the plurality of additionaltoggle bodies, the working suture passing into the proximal passage atthe top surface and out at the bottom surface, then back up through thedistal passage at the bottom surface out at the top surface of eachelongate body and leaving a length of suture extending past the middlepassage on the bottom surface of each elongate body, wherein eachadditional toggle body includes an independent locking loop extendingfrom the middle passage at the bottom surface with each locking loopencircling a portion of the length of the working suture of eachadditional toggle body extending past the middle passage along thebottom surface, the locking loop having a first open position allowingthe working suture to slide through the locking loop and a second closedposition engaging the working suture and preventing sliding of theworking suture within the locking loop; implanting the first toggle bodyinto the bone through the soft tissue at a selected location; implantinga first of the additional toggle bodies with the distal passage insertedfirst, through the soft tissue into bone spaced a selected distance fromthe first toggle body; applying tension to the working suture extendingfrom the distal passage top surface of the first additional toggle bodyto remove slack in the working suture between the first toggle body andfirst additional toggle body to form a tensioned first stitch while thetension also rotates the first additional toggle body into a securedposition within the bone; locking the working suture in the firstadditional toggle body after forming the first stitch to lock the firststitch between the first and first additional toggle body; implanting asecond of the additional toggle bodies with the distal passage insertedfirst, through the soft tissue into bone spaced a selected distance fromthe first additional toggle body; applying tension to the working sutureextending from the top surface of the distal passage of the secondadditional toggle body to remove slack in the working suture between thefirst additional toggle body and the second additional toggle body toform a tensioned second stitch while the tension also rotates the secondadditional toggle body into a secured position within the bone; lockingthe working suture in the second additional toggle body after formingthe second stitch to lock the second stitch between the first additionaltoggle body and the second additional toggle body; and repeating theimplanting, tensioning and locking steps for each additional toggle bodyto create additional serial tensioned and locked stitches.
 12. Themethod of claim 11, wherein the plurality of additional toggle bodiesincludes at least three toggle bodies.
 13. The method of claim 11,wherein the plurality of additional toggle bodies includes at least fivetoggle bodies.
 14. The method of claim 11, wherein the working suture isa round braided suture.
 15. The method of claim 11, wherein the step ofimplanting each toggle body includes insertion of the toggle body into apreformed bone hole having a diameter of less than about 3.0 mm.
 16. Themethod of claim 15, wherein each implanted toggle body is positionedless than or equal to about 7.0 mm. from the previous implanted togglebody.
 17. The method of claim 16, wherein: the soft tissue is a tendonto be repaired; wherein the tendon to be repaired has been separatedfrom an original footprint thereof on the bone; and the toggle bodiesare each implanted in the original footprint of the repaired tendon. 18.The method of claim 17 wherein the toggle bodies are each implanted in amedial portion of the original footprint.
 19. The method of claim 17,wherein the stitches extend generally laterally across the tendon andoriginal tendon footprint.